Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

PHASE4CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

February 4, 2020

Primary Completion Date

October 6, 2022

Study Completion Date

February 22, 2023

Conditions
ObesityPostoperative PainPostoperative NauseaPostoperative VomitingOpioid Use
Interventions
DRUG

Dexmedetomidine Hydrochloride [Dexdor]

Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation.

DRUG

Remifentanil [Ultiva]

Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.

DRUG

Ketamine [Ketalar]

Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.

DRUG

Lidocaine [Xylocaine 2%]

Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation.

DRUG

Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]

Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.

DRUG

Fentanyl [Fentanyl WZF]

Rescue dosis of 100 mcg iv will be administered if hypertension \> 140/90 mmHg or tachycardia \> 120min occurs. If necessary rescue dosis may be repeated.

Trial Locations (1)

02-005

Szpital Kliniczny Dzieciatka Jezus, Warsaw

All Listed Sponsors
lead

Medical University of Warsaw

OTHER

NCT04260659 - Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy | Biotech Hunter | Biotech Hunter