Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:30 AM
Study NCT ID:
NCT07337135
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emanueljoao7@gmail.com', 'phone': '+351963502309', 'title': 'Emanuel Almeida', 'organization': 'Hospital Lusíadas Amadora, Portugal'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study was conducted at a single center with a relatively small sample size, which may limit the generalizability of the findings. The trial was retrospectively registered, and some intraoperative measurements (NOL index) were available only for a subset of participants, with the number of observations varying across time points due to differences in surgical duration. Differences in antiemetic prophylaxis between groups may also have influenced postoperative nausea and vomiting outcomes.'}}, 'adverseEventsModule': {'timeFrame': 'Periprocedurally, up to 48 hours postoperatively.', 'description': 'Participants were monitored for adverse events from surgery until hospital discharge. Serious and non-serious adverse events were actively assessed and recorded according to standard institutional perioperative monitoring protocols. No adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU)', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}, {'title': 'At PACU discharge (assessed up to 2 hours after PACU admission)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Within the first 24 postoperative hours;', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': '48 hours postoperatively (at hospital discharge)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time Frame: - Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU); - At PACU discharge (assessed up to 2 hours after PACU admission); - Within the first 24 postoperative hours; - 48 hours postoperatively (at hospital discharge).', 'description': 'Postoperative pain will be assessed using the Numerical Rating Scale for Pain (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate a worse outcome, reflecting greater pain intensity.\n\nPain intensity will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group at predefined postoperative time points.', 'unitOfMeasure': 'Score on a scale (0-10)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis of postoperative pain intensity. Pain assessments were available for all participants at the predefined time points, and no participants were excluded from this outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Intraoperative Nociception (NOL Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'NOL index at 15 minutes: <10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 15 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 30 minutes: <10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 30 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 30 minutes: 26-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 45 minutes: <10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 45 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 45 minutes: 26-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 60 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 60 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 60 minutes: 26-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 75 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 75 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 75 minutes: 26-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 90 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 90 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 90 minutes: 26-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 105 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 105 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 105 minutes: 26-45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 120 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 120 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 135 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 135 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 150 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 150 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 165 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 180 minutes: < 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'NOL index at 180 minutes: 10-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Multiple standardized time points during surgery (15 to 180 minutes)', 'description': 'Nociception will be assessed using the NOL (Nociception Level) Index, a multiparametric autonomic signal-based monitor. Lower values reflect better nociceptive control. Comparisons will be made between OFA and OBA groups at all recorded time points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intraoperative NOL measurements were available only for a subset of participants. The number of participants contributing data at each time point varied due to differences in surgical duration, as later time points were reached only by longer procedures.'}, {'type': 'SECONDARY', 'title': 'Need for Rescue Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'Yes - Required rescue analgesia', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'No - Did not require rescue analgesia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '- During PACU stay (assessed up to 2 hours after PACU admission).', 'description': 'The proportion of patients requiring rescue analgesia (tramadol and/or morphine) will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis of rescue analgesia requirements. Data on the need for rescue analgesia were available for all participants, and no participants were excluded from this outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'Yes - Received opioids', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'No - Did not receive opioids', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '- During PACU stay (assessed up to 2 hours after PACU admission).', 'description': 'Need for opioid administration as rescue analgesia will be recorded and compared between groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of opioid use included only participants who required rescue analgesia during the PACU stay (assessed up to 2 hours after PACU admission). Among these participants, opioid administration was recorded. Participants who did not require rescue analgesia were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Incidence of Postoperative Nausea and Vomiting (PONV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'PONV Impact Scale score at 6 hours: 0', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 6 hours: 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 6 hours: 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 6 hours: ≥3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 24 hours: 0', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 24 hours: 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 24 hours: 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'PONV Impact Scale score at 24 hours: ≥3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 hours and 24 hours after surgery', 'description': 'PONV will be assessed using the Postoperative Nausea and Vomiting Impact Scale, comparing frequency and severity between groups. The total score ranges from 0 (no nausea or vomiting) to 6 (maximum impact). Higher scores indicate a worse outcome, reflecting greater severity and clinical impact of postoperative nausea and vomiting.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis of postoperative nausea and vomiting. PONV data were available for all participants at the predefined postoperative time points, and no participants were excluded from this outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Need for PONV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'Yes - Required PONV treatment', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'No - Did not require PONV treatment', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First 24 postoperative hours', 'description': 'Proportion of patients requiring antiemetic treatment will be evaluated and compared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis of the need for treatment of postoperative nausea and vomiting. Data were available for all participants, and no participants were excluded from this outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours postoperatively (at hospital discharge).', 'description': 'Patient satisfaction will be assessed using a Numerical Satisfaction Rating Scale and compared between groups. Total score ranges from 1 (minimum satisfaction) to 10 (maximum satisfaction). Higher scores indicate a better outcome, reflecting greater patient satisfaction.', 'unitOfMeasure': 'Score on a scale (1-10)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis of patient satisfaction. Satisfaction scores were available for all participants at hospital discharge, and no participants were excluded from this outcome analysis.'}, {'type': 'SECONDARY', 'title': 'Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'OG001', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}], 'classes': [{'title': 'Yes - Experienced postoperative complications', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No - No postoperative complications', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Periprocedurally, up to 48 hours postoperatively.', 'description': 'Occurrence of perioperative complications (respiratory, cardiovascular, surgical, or anesthesia-related) will be recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were included in the analysis of postoperative complications. Data were available for all participants during the hospital stay, and no participants were excluded from this outcome analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}, {'id': 'FG001', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were consecutively recruited at a single tertiary bariatric surgery center (Hospital Lusíadas Amadora, Portugal). Eligible adult patients scheduled for elective laparoscopic bariatric surgery were identified during routine preoperative outpatient consultations. All patients received verbal and written study information, and written informed consent was obtained prior to enrollment. Recruitment continued until the target sample size of 60 participants was achieved.', 'preAssignmentDetails': 'After enrollment and informed consent, no significant events, exclusions, or withdrawals occurred prior to randomization. All participants were assigned to their respective study groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.'}, {'id': 'BG001', 'title': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '42.7', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '44.9', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Age was recorded in years at the time of surgery, based on the participant's date of birth documented in the medical record.", 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age data were available for all randomized participants, and no participants were excluded from this baseline measure.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Biological sex was recorded as male or female, as documented in the participant's medical record at the time of enrollment.", 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex data were available for all randomized participants, and no participants were excluded from this baseline measure.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Portugal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were enrolled at a single clinical site located in Europe, specifically in Portugal.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Region of enrollment information was available for all randomized participants, with no differences between the numbers reported for this measure and the overall study population.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.3', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '5.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index was calculated as weight in kilograms divided by height in meters squared (kg/m²), measured during the preoperative assessment prior to surgery.', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Relevant Comorbidities', 'classes': [{'title': 'Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Type 2 Diabetes Mellitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'OSAS / OHS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Dyslipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Relevant comorbidities included hypertension, type 2 diabetes mellitus, obstructive sleep apnea syndrome or obesity hypoventilation syndrome (OSAS/OHS), depression and dyslipidemia, as documented in the preoperative medical records based on established clinical diagnoses.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants were included in the baseline analysis. No participants or units were excluded from baseline analyses.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-02-04', 'size': 173163, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-22T15:17', 'hasProtocol': True}, {'date': '2023-07-01', 'size': 160275, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2026-01-15T12:16', 'hasProtocol': False}, {'date': '2023-07-01', 'size': 158126, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-10T12:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No blinding was implemented. Both participants and care providers were aware of group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, two-arm parallel-group clinical trial comparing opioid-free anesthesia versus opioid-based anesthesia in patients undergoing laparoscopic bariatric surgery.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2025-12-10', 'resultsFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2026-02-22', 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Intensity Measured by the Numerical Rating Scale for Pain (NRS)', 'timeFrame': 'Time Frame: - Within 30 minutes of arrival at the Post-Anesthesia Care Unit (PACU); - At PACU discharge (assessed up to 2 hours after PACU admission); - Within the first 24 postoperative hours; - 48 hours postoperatively (at hospital discharge).', 'description': 'Postoperative pain will be assessed using the Numerical Rating Scale for Pain (NRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate a worse outcome, reflecting greater pain intensity.\n\nPain intensity will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group at predefined postoperative time points.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative Nociception (NOL Index)', 'timeFrame': 'Multiple standardized time points during surgery (15 to 180 minutes)', 'description': 'Nociception will be assessed using the NOL (Nociception Level) Index, a multiparametric autonomic signal-based monitor. Lower values reflect better nociceptive control. Comparisons will be made between OFA and OBA groups at all recorded time points.'}, {'measure': 'Need for Rescue Analgesia', 'timeFrame': '- During PACU stay (assessed up to 2 hours after PACU admission).', 'description': 'The proportion of patients requiring rescue analgesia (tramadol and/or morphine) will be compared between the opioid-free anesthesia group and the opioid-based anesthesia group.'}, {'measure': 'Opioid Consumption', 'timeFrame': '- During PACU stay (assessed up to 2 hours after PACU admission).', 'description': 'Need for opioid administration as rescue analgesia will be recorded and compared between groups.'}, {'measure': 'Incidence of Postoperative Nausea and Vomiting (PONV)', 'timeFrame': 'At 6 hours and 24 hours after surgery', 'description': 'PONV will be assessed using the Postoperative Nausea and Vomiting Impact Scale, comparing frequency and severity between groups. The total score ranges from 0 (no nausea or vomiting) to 6 (maximum impact). Higher scores indicate a worse outcome, reflecting greater severity and clinical impact of postoperative nausea and vomiting.'}, {'measure': 'Need for PONV Treatment', 'timeFrame': 'First 24 postoperative hours', 'description': 'Proportion of patients requiring antiemetic treatment will be evaluated and compared.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '48 hours postoperatively (at hospital discharge).', 'description': 'Patient satisfaction will be assessed using a Numerical Satisfaction Rating Scale and compared between groups. Total score ranges from 1 (minimum satisfaction) to 10 (maximum satisfaction). Higher scores indicate a better outcome, reflecting greater patient satisfaction.'}, {'measure': 'Postoperative Complications', 'timeFrame': 'Periprocedurally, up to 48 hours postoperatively.', 'description': 'Occurrence of perioperative complications (respiratory, cardiovascular, surgical, or anesthesia-related) will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid-free anesthesia', 'Bariatric surgery', 'Morbid obesity', 'Nausea and Vomiting', 'Postoperative pain'], 'conditions': ['Morbid Obesity', 'Postoperative Pain', 'Opioid Free Anesthesia', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled trial aims to compare the clinical effectiveness and safety of opioid-free anesthesia (OFA) versus traditional opioid-based anesthesia (OBA) in adult patients undergoing laparoscopic bariatric surgery. The study evaluates postoperative pain, need for rescue analgesia, incidence of postoperative nausea and vomiting (PONV), intraoperative nociception monitoring (NOL index), and patient satisfaction. A total of 60 patients were randomized into two parallel groups receiving either OFA or OBA according to standardized anesthetic protocols.', 'detailedDescription': 'Bariatric surgery is the most effective treatment for severe and morbid obesity, but perioperative pain management and PONV remain significant challenges. Traditional opioid-based anesthesia is associated with adverse effects such as respiratory depression, postoperative hyperalgesia, ileus, and delayed recovery.\n\nOpioid-free anesthesia is an emerging strategy based on the use of multimodal, non-opioid agents-including dexmedetomidine, lidocaine, and ketamine-aimed at providing adequate analgesia while reducing opioid-related complications.\n\nThis randomized controlled trial evaluates whether OFA improves postoperative pain control, reduces the requirement for rescue analgesia, and promotes better perioperative outcomes compared to OBA in laparoscopic bariatric surgery. Outcomes include NRS pain scores at multiple time points, NOL monitoring during surgery, PONV occurrence, and patient satisfaction at discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Body mass index (BMI ≥ 35 kg/m² with associated comorbidities) or BMI ≥ 40 kg/m²;\n* Scheduled for elective laparoscopic bariatric surgery;\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnancy;\n* History of substance abuse;\n* Severe psychiatric disease;\n* Contraindications to any of the drugs used in either anesthetic protocol (dexmedetomidine, ketamine, lidocaine, remifentanil, etc.);\n* Inability to comply with study procedures;\n* Refusal or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07337135', 'briefTitle': 'Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital dos Lusíadas'}, 'officialTitle': 'Opioid-free Anesthesia vs Opioid-based Anesthesia / A Heavyweight Showdown - Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CESHLAM17072023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid-Based Anesthesia (OBA)', 'description': 'Standard opioid-based anesthesia using remifentanil infusion plus propofol induction, desflurane maintenance, and conventional multimodal analgesia, with opioids permitted for rescue.', 'interventionNames': ['Drug: Opioid-Based Anesthesia (Remifentanil-Based Protocol)']}, {'type': 'EXPERIMENTAL', 'label': 'Opioid-Free Anesthesia (OFA)', 'description': 'Opioid-free anesthesia using dexmedetomidine, ketamine, and lidocaine infusion, combined with propofol induction, desflurane maintenance, and opioid-free multimodal analgesia, continued into early recovery.', 'interventionNames': ['Drug: Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)']}], 'interventions': [{'name': 'Opioid-Based Anesthesia (Remifentanil-Based Protocol)', 'type': 'DRUG', 'description': 'Participants receive standard opioid-based general anesthesia consisting of:\n\n* Continuous remifentanil infusion (2 mg diluted in 40 mL saline),\n* Propofol for induction,\n* Rocuronium for neuromuscular blockade,\n* Desflurane for maintenance,\n* Dexamethasone 4-8 mg for PONV prophylaxis,\n* Cefazolin for antibiotic prophylaxis,\n* Esomeprazole for stress-ulcer prevention.\n\nPostoperative analgesia includes paracetamol + ketorolac/parecoxib + metamizole, with tramadol and/or morphine provided as rescue. NOL, BIS, TOF, and standard monitoring are used.', 'armGroupLabels': ['Opioid-Based Anesthesia (OBA)']}, {'name': 'Opioid-Free Anesthesia (Dexmedetomidine-Ketamine-Lidocaine Protocol)', 'type': 'DRUG', 'description': 'Participants receive opioid-free anesthesia consisting of:\n\n* Dexmedetomidine bolus (15-20 μg),\n* Continuous infusion of dexmedetomidine 50 μg + ketamine 50 mg + lidocaine 500 mg in 50 mL saline (rate: 1 mL/10 kg),\n* Propofol for induction,\n* Rocuronium for neuromuscular blockade,\n* Desflurane for maintenance,\n* Dexamethasone for PONV prophylaxis,\n* Cefazolin and esomeprazole for prophylaxis.\n* The analgesic infusion is reduced by half 30 min before end of surgery and continued for 1 hour in PACU.\n\nPostoperative analgesia includes paracetamol + ketorolac/parecoxib + metamizole, with tramadol 100 mg as rescue. Monitoring includes NOL, BIS, TOF.', 'armGroupLabels': ['Opioid-Free Anesthesia (OFA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2724-002', 'city': 'Amadora', 'country': 'Portugal', 'facility': 'Hospital Lusíadas Amadora - Lusíadas Saúde, S.A.', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}], 'overallOfficials': [{'name': 'Emanuel J Almeida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital dos Lusíadas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to privacy restrictions and institutional regulations. Only aggregated results will be made available in publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital dos Lusíadas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesiologist', 'investigatorFullName': 'Emanuel João Gonçalves Ferreira de Almeida', 'investigatorAffiliation': 'Hospital dos Lusíadas'}}}}