Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass
Study Details
Study Description
Brief Summary
Opioid free anesthesia is a recent anesthesia technique with the aim to avoid peroperative use of morphinics to allow a diminution of secondary morphinics effects in the postoperative period.
There is no robust data on the real benefits of such procedures. Obese patients are particular at risk of secondary effects of opioids. The aim of our study is to compare opioid free anesthesia to multimodal anesthesia on postoperative morphine consumption after a laparoscopic gastric bypass.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The aim of the study is to study the impact of an opioid free anesthesia protocol on the postoperative morphine consumption in laparoscopic gastric bypass compared to a multimodal anesthesia protocol.
200 morbidly obese patients (Body mass index >40Kg/m2 or >35kg/m2 AND/OR diabete mellitus AND/OR sleep apnea syndrome AND/OR arterial hypertension.
A randomization will allocate two groups of 100 patients in:
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Group 1: Multimodal anesthesia without opioids
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Group 2: Multimodal anesthesia with opioid sparing The patient, the anesthésist and the data evaluator will be blinded about the allocation of the patient.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Opioid free anesthesia Dexmedetomidine 0,5 microgrammes/kg of ideal body weight (IBW) + magnesium 40 mg/kg of total body weight (TBW) in 10 minutes Dexmedetomidine 0,4- 0,8 microgrammes/kg of IBW/h;Lidocaine 2% 49ml+ Ketamine 50mg: 1ml/10kg of IBW/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ KgTBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;dexmedetomidine: 0,4-0,8 microgramme/kg/h;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence Stop dexmedetomidine;Stop sevorane;1 ml of NaCL 0,9%;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Lidocaïne 2% 49ml + Ketamine 50 mg: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours |
Drug: Dexmedetomidine Injection [Precedex]
dexmedetomidine or remifentanil during laparoscopic gastric bypass
|
| Experimental: Multimodal anesthesia magnesium 40 mg/kg of total body weight (TBW) in 10 minutes Remifentanil 0,2-0,4 microgrammes/kg/min of ideal body weight; Saline 0,9%: Infusion at 1ml/10kg of ideal body weight/ hour;Ketamine 25 mg;lidocaïne 1,5 mg/kg IBW;Propofol 2mg/kgTBW;Rocuronium 1,2 mg/kg IBW;Cefazoline 2g if >120 kg, 3g if >120Kg;Paracetamol 15 mg/ Kg TBW;Diclofenac 75 mg;Dexamethasone 10 mg;Ondansetron 4 mg;Sevorane;remifentanil 0,2-0,4 microgrammes/kg/min;Rocuronium 0,1 mg/kg of IBW if posttetanic count>1/10;Atropine 0,5 mg if heart rate < 40/min;Ephedrine 5mg in Arterial mean pressure < 20% of basal value;Nicardipine 0,5 mg if Arterial mean pressure > 20% of basal value Emergence Stop remifentanil;Stop sevorane;1 ml of morphine 10mg/ml;Suggamadex 4 mg/ kg of IBW+ 4mg/kg of 40% ABW Post-anesthesia:Salne 50ml: 0,5 ml/ 10 kg IBW;Paracetamol 1g/6h;Diclofenac 75mg/12h;Morphine patient controlled analgesia: 1 mg/5 min, maximum 20mg/ 4 hours |
Drug: Remifentanil
dexmedetomidine or remifentanil during laparoscopic gastric bypass
|
Outcome Measures
Primary Outcome Measures
- Total Morphine consumption [24 hours after surgery]
Secondary Outcome Measures
- Visual analog scale [Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24]
- Morphine consumption [Post Anesthesia Care Unit admission (Hour 0), Hour +4]
- Quality of Recovery 40 score [operative Day -1, Operative day +1, operative day +30]
Recovery scale: From 40 (worst recovery) to 200 (Best Recovery)
- Hypoxemia [up to patient discharge]
SpO2 < 90% on 2 liters of nasal Oxygen
- Postoperative Nausea and vomiting [Post Anesthesia Care Unit admission (Hour 0), Hour +4, Hour +24]
- Time to obtain Aldrete score >9 [Up to Postanesthesia care unit discharge]
Scale from 0 (worst) to 10 (Best)
- Need of Antiemetics [Up to patient discharge]
- Bradycardia and use of atropine [Up to patient discharge]
- Minimal Alveolar Concentration to obtain sedline 30-50 [during surgery]
Sedline (MassimoTM) is a tool to assess the depth of anesthesia
- Nociception level index [during surgery]
- Time to obtain discharge criteria [up to patient discharge]
in hours
- Clavien Dindo Scale [Up to 30 days]
Postoperative complication from Grade 1 (no intervention) to 5 (death)
- Readmissions rate [Up to 30 days]
Admission of the patient in hospital during the first 30 postoperative days
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of anesthesia score (ASA) 2-3
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Scheduled for a laparoscopic gastric bypass
Exclusion Criteria:
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Patient refusal
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Medical diseases: Cardiac arrhythmia like atrioventricular block 2nd or 3rd degree, pacemaker, arterial hypotension, severe bradycardia, cerebrovascular pathology, renal and/or hepatic insufficiency
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Previous bariatric surgery
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Allergy to any medication used during the surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHIREC Delta Hospital | Brussels | Belgium | 1160 |
Sponsors and Collaborators
- matthieu clanet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P2021/378