Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT06985069
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Multimodal Anesthesia Bern
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)', 'timeFrame': 'Postoperative day 1', 'description': 'QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction'}], 'secondaryOutcomes': [{'measure': 'Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)', 'timeFrame': 'Postoperative day 2', 'description': 'QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction'}, {'measure': 'Safety outcome 1a respiratory: respiratory rate', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Number of patients with reported respiratory rate of less than 8 per minute'}, {'measure': 'Safety outcome 1b respiratory: airway obstruction needing an intervention', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Number of patients with reported airway obstruction needing an intervention (e.g. insertion of a naso-pharyngeal-tube)'}, {'measure': 'Safety outcome 1c respiratory: desaturation', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Number of patients with reported desaturation (peripheral oxygen saturation \\< 92%) despite administration of nasal oxgen (max. 6l/min.)'}, {'measure': 'Safety outcome 2a cardiac: hypotension', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Number of patients with reported hypotension needing an intervention'}, {'measure': 'Safety outcome 2b cardiac: bradycardia', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Number of patients with reported heart rate lower than 60 beats per minute needing an intervention'}, {'measure': 'Safety outcome 2c cardiac: conduction block', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Number of patients with a postoperatively new reported conduction block'}, {'measure': 'Postoperative data 1: pain scores measured by numeric rating scale (NRS)', 'timeFrame': 'At arrival and after 6 hours/before leaving post-anesthesia care unit (PACU, expected up to 1 day) or intermediate care (IMC)', 'description': 'NRS ranging from 0 to 10, with higher scores corresponding to more postoperative pain'}, {'measure': 'Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)', 'timeFrame': 'Maximal values during stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'RASS ranging from -5 until +4 with negative values corresponding to progressive sedation, positive values corresponding to progressive delirium'}, {'measure': 'Postoperative data 3: severity of postoperative nausea and vomiting', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'percentage of patients with either:\n\n* no nausea\n* nausea without vomiting\n* nausea with vomiting\n* \\>3 times vomiting in 30 minutes'}, {'measure': 'Postoperative data 4: oxygen use', 'timeFrame': 'During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day', 'description': 'Maximal administered oxygen (\\[l/min.\\]'}, {'measure': 'Opioid consumption in the post-operative period', 'timeFrame': 'First 48 hours postoperatively', 'description': 'Oral morphine milligram equivalents mg'}, {'measure': 'Impact on long-term opioid use after hospital discharge', 'timeFrame': 'Hospital discharge (expected up to 3 weeks)', 'description': 'Percentage of patients with a new opioid prescription after hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multimodal anesthesia'], 'conditions': ['Opioid Use', 'Pain, Postoperative', 'Postoperative Complications', 'Postoperative Nausea']}, 'descriptionModule': {'briefSummary': 'In the context of the ongoing opioid crisis in the USA and Europe, reducing perioperative opioid use is a growing priority. Multimodal anesthesia (MMA) offers a patient-centered alternative to opioid-free anesthesia, combining regional techniques, non-opioid analgesics, and adjunct therapies to enhance pain control while minimizing opioid reliance. By targeting multiple pain pathways, MMA can improve recovery outcomes, reduce side effects, and optimize resource use, representing a potential paradigm shift in perioperative medicine.\n\nThis study compares (patient-centered) outcomes after application of MMA (a standardized combination of Magnesium, Ketamine, Lidocain and Dexmedetomidine before and during surgery in combination with opioids) with an opioid based general anesthesia regimen in the context of major surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Existing informed consent\n* German, Italian or French speaking\n* Age 18 or more\n* Planned duration of surgery 60min or more\n* Inpatients and postoperative transfer to PACU or 24h ICU\n\nExclusion Criteria:\n\n* Palliative or emergency procedures\n* Reoperation (e.g. 2nd look)\n* Bariatric surgery patients\n* Pregnancy / breastfeeding\n* Adults legally protected\n* Known allergy or contraindication to interventional medication'}, 'identificationModule': {'nctId': 'NCT06985069', 'briefTitle': 'Outcome of Multimodal Anesthesia Bern', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Impact of Multimodal Versus Opioid-Only Anesthesia on Short Term Quality of Recovery After Major Surgery: A Randomized Prospective Single-Center Superiority Trial', 'orgStudyIdInfo': {'id': 'MMA 25-01'}, 'secondaryIdInfos': [{'id': '2025-00283', 'type': 'OTHER', 'domain': 'Business Administration System for Ethics Committees (BASEC)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal anesthesia-group', 'description': 'The intervention consists of the application of a standardized combination of Magnesium, Ketamine, Lidocaine and Dexmedetomidine before and during surgery in combination with opioids (Fentanyl, Methadone, and Hydromorphon) in a non-standardized fashion for perioperative pain control.', 'interventionNames': ['Procedure: General anesthesia applying multimodal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid based-group', 'description': 'Patients in the control group will be treated with opioids only (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist for perioperative pain control.', 'interventionNames': ['Procedure: General anesthesia using conventional opioid-based regimen']}], 'interventions': [{'name': 'General anesthesia applying multimodal anesthesia', 'type': 'PROCEDURE', 'description': 'In the multimodal anesthesia-group a combination of different opioid-sparing drugs are added for general anesthesia, dosages are as follows:\n\n* Magnesium 2g IV\n* Dexmedetomidine IV 0.3mcg/kg IBW bolus over 10 minutes, followed by 0.3mcg/kg IBW until 30 min. before the end of surgery or the maximal dosage of 1.4mcg/kg IBW.\n* Ketamine IV 0.3mg/kg IBW bolus, followed by 0.3 mg/kg IBW or a max. Dose of 25mg/h, until 30 min. before the end of surgery.\n* Lidocaine IV 1mg/kg IBW bolus, followed by 1mg/kg/h IBW until in PACU/ICU', 'armGroupLabels': ['Multimodal anesthesia-group']}, {'name': 'General anesthesia using conventional opioid-based regimen', 'type': 'PROCEDURE', 'description': 'Opioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist', 'armGroupLabels': ['Opioid based-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Patrick Wüthrich, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}