Opioid Use, Pain, Postoperative, Postoperative Complications, Postoperative Nausea
Conditions
Keywords
Multimodal anesthesia
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.
Interventions
PROCEDUREGeneral 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
PROCEDUREGeneral anesthesia using conventional opioid-based regimen
Opioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15 questionnaire with 15 questions) | Postoperative day 1 | QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of patients with reported respiratory rate of less than 8 per minute |
| 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 | Number of patients with reported airway obstruction needing an intervention (e.g. insertion of a naso-pharyngeal-tube) |
| Safety outcome 1c respiratory: desaturation | 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.) |
| Safety outcome 2a cardiac: hypotension | 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 |
| Safety outcome 2b cardiac: bradycardia | 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 |
| Safety outcome 2c cardiac: conduction block | 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 |
| Evolution of Patient centered satisfaction measured by the QoR-15 (Quality of Recovery-15-questionnaire) | Postoperative day 2 | QoR-15 is a score from 0 to 150 with higher scores corresponding to greater patient satisfaction |
| Postoperative data 2: sedation score & delirium rate measured by the Richmond Agitation-Sedation Scale (RASS) | 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 |
| Postoperative data 3: severity of postoperative nausea and vomiting | 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 |
| Postoperative data 4: oxygen use | During stay in post-anesthesia care unit (PACU) or intermediate care IMC (expected to be) up to 1 day | Maximal administered oxygen (\[l/min.\] |
| Opioid consumption in the post-operative period | First 48 hours postoperatively | Oral morphine milligram equivalents mg |
| Impact on long-term opioid use after hospital discharge | Hospital discharge (expected up to 3 weeks) | Percentage of patients with a new opioid prescription after hospital discharge |
| Postoperative data 1: pain scores measured by numeric rating scale (NRS) | 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 |
Countries
Switzerland
Outcome results
None listed