Outcome of Multimodal Anesthesia Bern

Not Applicable

Not yet recruiting

• Conditions: Opioid Use; Postoperative Complications; Pain, Postoperative; Postoperative Nausea

• Registration Number: NCT06985069
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

This 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Existing informed consent
• German, Italian or French speaking
• Age 18 or more
• Planned duration of surgery 60min or more
• Inpatients and postoperative transfer to PACU or 24h ICU

Exclusion Criteria

• Palliative or emergency procedures
• Reoperation (e.g. 2nd look)
• Bariatric surgery patients
• Pregnancy / breastfeeding
• Adults legally protected
• Known allergy or contraindication to interventional medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)	Postoperative day 1	QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction

Secondary Outcome Measures

Name	Time	Method
Safety outcome 2a cardiac: hypotension	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Number of patients with reported hypotension needing an intervention
Safety outcome 2b cardiac: bradycardia	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Number of patients with reported heart rate lower than 60 beats per minute needing an intervention
Safety outcome 2c cardiac: conduction block	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Number of patients with a postoperatively new reported conduction block
Postoperative data 1: pain scores measured by numeric rating scale (NRS)	At arrival and after 6 hours/before leaving post-anesthesia care unit (PACU, expected up to 1 day) or intermediate care (IMC)	NRS ranging from 0 to 10, with higher scores corresponding to more postoperative pain
Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)	Maximal values during stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	RASS ranging from -5 until +4 with negative values corresponding to progressive sedation, positive values corresponding to progressive delirium
Postoperative data 3: severity of postoperative nausea and vomiting	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	percentage of patients with either: * no nausea; * nausea without vomiting; * nausea with vomiting; * \>3 times vomiting in 30 minutes
Postoperative data 4: oxygen use	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Maximal administered oxygen (\[l/min.\]
Opioid consumption in the post-operative period	First 48 hours postoperatively	Oral morphine milligram equivalents mg
Impact on long-term opioid use after hospital discharge	Hospital discharge (expected up to 3 weeks)	Percentage of patients with a new opioid prescription after hospital discharge
Safety outcome 1c respiratory: desaturation	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Number of patients with reported desaturation (peripheral oxygen saturation \< 92%) despite administration of nasal oxgen (max. 6l/min.)
Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)	Postoperative day 2	QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction
Safety outcome 1b respiratory: airway obstruction needing an intervention	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Number of patients with reported airway obstruction needing an intervention (e.g. insertion of a naso-pharyngeal-tube)
Safety outcome 1a respiratory: respiratory rate	During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day	Number of patients with reported respiratory rate of less than 8 per minute

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital; 🇨🇭 Bern, Switzerland