An interventional study of General anesthesia applying multimodal anesthesia and General anesthesia using conventional opioid-based regimen in Opioid Use, Pain, Postoperative and Postoperative Complications, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 240 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
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
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
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
Opioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist
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
Time frame: Postoperative day 1
Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire)
QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction
Time frame: Postoperative day 2
Safety outcome 1a respiratory: respiratory rate
Number of patients with reported respiratory rate of less than 8 per minute
Time frame: 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
Number of patients with reported airway obstruction needing an intervention (e.g. insertion of a naso-pharyngeal-tube)
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 1c respiratory: desaturation
Number of patients with reported desaturation (peripheral oxygen saturation \< 92%) despite administration of nasal oxgen (max. 6l/min.)
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2a cardiac: hypotension
Number of patients with reported hypotension needing an intervention
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2b cardiac: bradycardia
Number of patients with reported heart rate lower than 60 beats per minute needing an intervention
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Safety outcome 2c cardiac: conduction block
Number of patients with a postoperatively new reported conduction block
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 1: pain scores measured by numeric rating scale (NRS)
NRS ranging from 0 to 10, with higher scores corresponding to more postoperative pain
Time frame: At arrival and after 6 hours/before leaving post-anesthesia care unit (PACU, expected up to 1 day) or intermediate care (IMC)
Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS)
RASS ranging from -5 until +4 with negative values corresponding to progressive sedation, positive values corresponding to progressive delirium
Time frame: Maximal values during stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 3: severity of postoperative nausea and vomiting
percentage of patients with either: * no nausea * nausea without vomiting * nausea with vomiting * \>3 times vomiting in 30 minutes
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Postoperative data 4: oxygen use
Maximal administered oxygen (\[l/min.\]
Time frame: During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day
Opioid consumption in the post-operative period
Oral morphine milligram equivalents mg
Time frame: First 48 hours postoperatively
Impact on long-term opioid use after hospital discharge
Percentage of patients with a new opioid prescription after hospital discharge
Time frame: Hospital discharge (expected up to 3 weeks)
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern