Clinical trial NCT06985069: Outcome of Multimodal Anesthesia Bern
Official title: Impact of Multimodal Versus Opioid-Only Anesthesia on Short Term Quality of Recovery After Major Surgery: A Randomized Prospective Single-Center Superiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use
Pain, Postoperative
Postoperative Complications
Postoperative Nausea
Keywords: Multimodal anesthesia
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)
timeFrame: Postoperative day 2
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
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
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
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
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
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
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)
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
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
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
measure: Opioid consumption in the post-operative period
timeFrame: First 48 hours postoperatively
measure: Impact on long-term opioid use after hospital discharge
timeFrame: Hospital discharge (expected up to 3 weeks)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
name: Patrick Wüthrich, Professor
role: STUDY_CHAIR
References: