NCT04260659

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.

Detailed description

The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%. Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia. Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model. After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.

Conditions

• Obesity
• Postoperative Pain
• Postoperative Nausea
• Postoperative Vomiting
• Opioid Use

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-04
• Primary completion: 2022-10-06
• Completion: 2023-02-22
• First posted: 2020-02-07
• Last updated: 2023-03-08

Locations

1 site across 1 country: Poland