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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-00283 | Other Identifier | Business Administration System for Ethics Committees (BASEC) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Postoperative day 2 |
| Safety outcome 1a respiratory: respiratory rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Wüthrich, Professor | Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, Bern, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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Monocentric, randomized, double-blind (patients and outcome assessment), superiority, two-arm controlled trial
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| General anesthesia using conventional opioid-based regimen | Procedure | Opioids (Fentanyl, Methadone, Hydromorphone) at the discretion of the treating anesthetist |
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Number of patients with reported respiratory rate of less than 8 per minute |
| 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) | 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.) | 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 | 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 | 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 | 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 | 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 | 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:
| 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.] | 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 | First 48 hours postoperatively |
| Impact on long-term opioid use after hospital discharge | Percentage of patients with a new opioid prescription after hospital discharge | Hospital discharge (expected up to 3 weeks) |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |