Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT06464393
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2024-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid-based Versus Opioid-free Endotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in systolic arterial pressure after premedication', 'timeFrame': '30 seconds after premedication', 'description': 'baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in systolic arterial pressure immediately after premedication', 'timeFrame': 'immediately after intubation', 'description': 'baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in systolic arterial pressure 1 minute after intubation', 'timeFrame': '1 minute after intubation', 'description': 'baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in systolic arterial pressure 3 minutes after intubation', 'timeFrame': '3 minutes after intubation', 'description': 'baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in systolic arterial pressure 5 minutes after intubation', 'timeFrame': '5 minutes after intubation', 'description': 'baseline systolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in diastolic arterial pressure after premedication', 'timeFrame': '30 seconds after premedication', 'description': 'baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in diastolic arterial pressure 1 minute after intubation', 'timeFrame': '1 minute after intubation', 'description': 'baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in diastolic arterial pressure 3 minutes after intubation', 'timeFrame': '3 minutes after intubation', 'description': 'baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in diastolic arterial pressure 5 minutes after intubation', 'timeFrame': '5 minutes after intubation', 'description': 'baseline diastolic arterial pressure will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in heart rate after premedication', 'timeFrame': '30 seconds after premedication', 'description': 'baseline heart rate will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in heart rate 1 minute after intubation', 'timeFrame': '1 minute after intubation', 'description': 'baseline heart rate will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in heart rate 3 minutes after intubation', 'timeFrame': '3 minutes after intubation', 'description': 'baseline heart rate will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'change from baseline in heart rate 5 minutes after intubation', 'timeFrame': '5 minutes after intubation', 'description': 'baseline heart rate will be measured as soon as the patient settles in the operating theatre'}, {'measure': 'ST segment change 1 minute post intubation', 'timeFrame': '1 minute after intubation', 'description': 'ST segment elevation or depression after intubation'}, {'measure': 'ST segment change 3 minutes post intubation', 'timeFrame': '3 minutes after intubation', 'description': 'ST segment elevation or depression after intubation'}, {'measure': 'ST segment change 5 minutes post intubation', 'timeFrame': '5 minutes after intubation', 'description': 'ST segment elevation or depression after intubation'}, {'measure': 'duration of nociception level<25 for a 5-minute period after intubation', 'timeFrame': '5 minutes after intubation', 'description': 'nociception level (NOL) is a device that measures the status of analgesia intraoperatively. Levels\\<25 suggest adequate intraoperatively analgesia'}, {'measure': 'time required to achieve a train-of four-ratio of 0', 'timeFrame': 'within 2.5 minutes of neuromuscular blocking agent administration', 'description': 'the train-of-four (TOF) ratio measures the ratio of the fourth stimulus to the first stimulus of four twitches of neuromuscular stimulation. When this ration reaches the value of 0, the patient is considered ready for intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'Anesthesia Intubation', 'Opioid Use', 'Analgesic Non-narcotic', 'Fentanyl']}, 'referencesModule': {'references': [{'pmid': '3828177', 'type': 'BACKGROUND', 'citation': 'Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.'}, {'pmid': '19357514', 'type': 'BACKGROUND', 'citation': 'Theodoraki K, Fassoulaki A. Cardiovascular responses to laryngoscopy and tracheal intubation are not accompanied by ST-segment changes. Eur J Anaesthesiol. 2009 Jun;26(6):520-2. doi: 10.1097/EJA.0b013e32831a468d. No abstract available.'}, {'pmid': '36734737', 'type': 'BACKGROUND', 'citation': 'Vickovic S, Zdravkovic R, Radovanovic D, Galambos IF, Pap D, Krtinic D, Stanisavljevic S, Preveden M, Videnovic N, Videnovic J. Effect of different doses of remifentanil on the cardiovascular response after endotracheal intubation: a randomized double-blind study. Eur Rev Med Pharmacol Sci. 2023 Jan;27(2):653-658. doi: 10.26355/eurrev_202301_31067.'}, {'pmid': '37515877', 'type': 'BACKGROUND', 'citation': 'Feenstra ML, Jansen S, Eshuis WJ, van Berge Henegouwen MI, Hollmann MW, Hermanides J. Opioid-free anesthesia: A systematic review and meta-analysis. J Clin Anesth. 2023 Nov;90:111215. doi: 10.1016/j.jclinane.2023.111215. Epub 2023 Jul 27.'}, {'pmid': '38573179', 'type': 'BACKGROUND', 'citation': 'Patel J, Snyder K, Brooks AK. Perioperative pain optimization in the age of the opioid epidemic. Curr Opin Anaesthesiol. 2024 Jun 1;37(3):279-284. doi: 10.1097/ACO.0000000000001370. Epub 2024 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to investigate the effect of opioid-free induction versus opioid-based induction on hemodynamic response and nociception level index during elective operations', 'detailedDescription': 'Laryngoscopy and intubation stimuli can cause a sustained sympathetic response manifested as hypertension and tachycardia. Therefore, preadministration of opioid medication aiming at blunting this hemodynamic response is common in everyday anesthetic practice.\n\nOpioid-based anesthesia is associated with side-effects, such as respiratory depression, postoperative nausea and vomiting and occasional induction of tolerance and hyperalgesia.\n\nResearch in recent years has focused on the quest for non-opioid-based regimens (opioid-sparing and opioid-free techniques). Most of the relevant studies however focus on the advantages that opioid-free techniques bear on early and late postoperative patient recovery. Literature on the effect of opioid-free techniques especially on laryngoscopy, intubation and subsequent hemodynamic response.\n\nTherefore, the aim of this study will be the comparison of the hemodynamic response to laryngoscopy and intubation between two groups of patients: a group in which opioid medications will be administered before anesthetic induction and a group in which a combination of lidocaine, dexmedetomidine and ketamine will be administered before anesthetic induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* American Society of Anesthesiologists (ASA) classification I-II\n* Mallampati classification 1, 2 or 3\n\nExclusion Criteria:\n\n* anticipated difficult airway (Mallampati 4 classification, thyromental distance \\< 6 cm, mouth opening \\< 3 cm, neck extension\\< 80\n* atrioventricular block\n* bradycardia (heart rate less than 55/min)\n* preadministration of beta-blockers\n* eligibility for rapid-sequence induction\n* chronic use of opioid medications\n* known allergy to induction agents\n* history of psychiatric disease\n* language or communication barriers or lack of informed consent'}, 'identificationModule': {'nctId': 'NCT06464393', 'briefTitle': 'Opioid-based Versus Opioid-free Endotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Aretaieion University Hospital'}, 'officialTitle': 'The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation', 'orgStudyIdInfo': {'id': '548/02-02-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketamine-lidocaine-dexmedetomidine group', 'description': 'combination of ketamine-lidocaine-dexmedetomidine', 'interventionNames': ['Drug: ketamine-lidocaine-dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl group', 'description': 'fentanyl', 'interventionNames': ['Drug: fentanyl']}], 'interventions': [{'name': 'ketamine-lidocaine-dexmedetomidine', 'type': 'DRUG', 'otherNames': ['KLD group'], 'description': 'Patients will be administered 0,8 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes as premedication. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations just before induction of anesthesia.', 'armGroupLabels': ['ketamine-lidocaine-dexmedetomidine group']}, {'name': 'fentanyl', 'type': 'DRUG', 'otherNames': ['control group'], 'description': 'Patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes as premedication. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9% just before induction of anesthesia.', 'armGroupLabels': ['fentanyl group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Aretaieion University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'KASSIANI THEODORAKI, PhD, DESA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aretaieion University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Dr Kassiani Theodoraki', 'investigatorAffiliation': 'Aretaieion University Hospital'}}}}