Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass

matthieu clanet

Status: Completed

Conditions: Analgesics, Opioid

Treatments: Drug: Dexmedetomidine Injection [Precedex]; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05004519

P2021/378

Details and patient eligibility

About

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.

Full 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.

183 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:

• Group 1: Multimodal anesthesia without opioids
• Group 2: Multimodal anesthesia with opioid The patient, the anesthesist and the data evaluator will be all blinded about the allocation of the patient.

Enrollment: 183 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of anesthesia score (ASA) 2-3
• Scheduled for a laparoscopic gastric bypass surgery

Exclusion criteria

• Patient refusal
• Medical diseases: Cardiac arrhythmia like atrioventricular block 2nd or 3rd degree, pacemaker, arterial hypotension, severe bradycardia, cerebrovascular pathology, renal and/or hepatic insufficiency
• Previous bariatric surgery
• Allergy to any medication used during the surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 2 patient groups

Opioid free anesthesia

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

Multimodal anesthesia

Experimental group

Description:

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

Treatment:

Drug: Remifentanil