Outcome of Multimodal Anesthesia Bern

NCT ID: NCT06985069

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2025-09-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multimodal anesthesia-group

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.

Group Type: EXPERIMENTAL

General anesthesia applying multimodal anesthesia

Intervention Type: 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

Opioid based-group

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.

Group Type: ACTIVE_COMPARATOR

General anesthesia using conventional opioid-based regimen

Intervention Type: PROCEDURE

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

Interventions

General anesthesia applying multimodal anesthesia

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

Intervention Type: PROCEDURE

General anesthesia using conventional opioid-based regimen

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Wüthrich, Professor

Role: STUDY_CHAIR

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

Locations

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

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2025-00283

Identifier Type: OTHER

Identifier Source: secondary_id

MMA 25-01

Identifier Type: -

Identifier Source: org_study_id