Outcome of Multimodal Anesthesia Bern

NCT06985069 | Completed

• 2 other identifiers: MMA 25-012025-00283
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Pain, Postoperative; Postoperative Complications; Postoperative Nausea

Keywords

Multimodal anesthesia

Outcome Measures

Primary Outcomes (1)

• Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions)

  QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction

  Postoperative day 1

Secondary Outcomes (13)

• Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)

  Postoperative day 2

• 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

• 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

• Safety outcome 1c respiratory: desaturation

  During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day

• Safety outcome 2a cardiac: hypotension

  During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day

Study Arms (2)

Multimodal anesthesia-group

EXPERIMENTAL

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.

Procedure: General anesthesia applying multimodal anesthesia

Opioid based-group

ACTIVE COMPARATOR

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.

Procedure: General anesthesia using conventional opioid-based regimen

Interventions

General anesthesia applying multimodal anesthesia PROCEDURE

In the multimodal anesthesia-group a combination of different opioid-sparing drugs are added for general anesthesia, dosages are as follows: * Magnesium 2g IV * 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. * 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. * Lidocaine IV 1mg/kg IBW bolus, followed by 1mg/kg/h IBW until in PACU/ICU

Multimodal anesthesia-group

General anesthesia using conventional opioid-based regimen PROCEDURE

Opioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist

Opioid based-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Patrick Wüthrich, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 22, 2025
• Study Start: June 16, 2025
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)