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Completed

NCT Number: NCT06985069

Outcome of Multimodal Anesthesia Bern

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.

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Key information

Conditions

Opioid Use Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

General anesthesia using conventional opioid-based regimen

Procedure

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

Primary outcomes

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

    Time frame: Postoperative day 1

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

Secondary outcomes

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

    Time frame: Postoperative day 2

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

  2. Safety outcome 1a respiratory: respiratory rate

    Time frame: 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

  3. Safety outcome 1b respiratory: airway obstruction needing an intervention

    Time frame: 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)

  4. Safety outcome 1c respiratory: desaturation

    Time frame: 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.)

  5. Safety outcome 2a cardiac: hypotension

    Time frame: 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

  6. Safety outcome 2b cardiac: bradycardia

    Time frame: 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

  7. Safety outcome 2c cardiac: conduction block

    Time frame: 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

  8. Postoperative data 1: pain scores measured by numeric rating scale (NRS)

    Time frame: 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

  9. Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)

    Time frame: 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

  10. Postoperative data 3: severity of postoperative nausea and vomiting

    Time frame: 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

  11. Postoperative data 4: oxygen use

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

    Maximal administered oxygen ([l/min.]

  12. Opioid consumption in the post-operative period

    Time frame: First 48 hours postoperatively

    Oral morphine milligram equivalents mg

  13. Impact on long-term opioid use after hospital discharge

    Time frame: Hospital discharge (expected up to 3 weeks)

    Percentage of patients with a new opioid prescription after hospital discharge

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Impact of Multimodal Versus Opioid-Only Anesthesia on Short Term Quality of Recovery After Major Surgery: A Randomized Prospective Single-Center Superiority Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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