Benefits of Opioid Free Anesthesia on Morphine Consumptio... | NCT05004519

NCT05004519

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Opioid free anesthesia	Experimental	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]
Multimodal anesthesia	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine Injection [Precedex]	Drug	dexmedetomidine or remifentanil during laparoscopic gastric bypass	Opioid free anesthesia

Outcomes Module

Measure	Description	Time Frame
Total Morphine consumption	total morphine consumption from the PACU arrival to the 24 h post-surgery	24 hours after surgery

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Name	Affiliation	Role
matthieu Clanet	Chirec	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHIREC Delta Hospital		Brussels		1160	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38435809	Derived	Clanet M, Touihri K, El Haddad C, Goldsztejn N, Himpens J, Fils JF, Gricourt Y, Van der Linden P, Coeckelenbergh S, Joosten A, Dandrifosse AC. Effect of opioid-free versus opioid-based strategies during multimodal anaesthesia on postoperative morphine consumption after bariatric surgery: a randomised double-blind clinical trial. BJA Open. 2024 Feb 23;9:100263. doi: 10.1016/j.bjao.2024.100263. eCollection 2024 Mar.

ID	Term
D020927	Dexmedetomidine
D000077208	Remifentanil

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds