Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

NCT ID: NCT04260659

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2023-02-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Opioid liberal group

Group Type: ACTIVE_COMPARATOR

Remifentanil [Ultiva]

Intervention Type: DRUG

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

Opioid free group

Group Type: EXPERIMENTAL

Dexmedetomidine Hydrochloride [Dexdor]

Intervention Type: DRUG

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.

Ketamine [Ketalar]

Intervention Type: DRUG

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

Lidocaine [Xylocaine 2%]

Intervention Type: DRUG

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.

Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]

Intervention Type: DRUG

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

Fentanyl [Fentanyl WZF]

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Remifentanil [Ultiva]

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

Intervention Type: DRUG

Ketamine [Ketalar]

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

Intervention Type: 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.

Intervention Type: DRUG

Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
• Written informed consent

Exclusion Criteria

• Patient's refusal
• Known allergies to study medication
• Inability to comprehend or participate In pain scoring scale
• Inability to use intravenous patient controlled analgesia
• Changes of operation extent during procedure
• Revisional operations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Mieszczański, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Szpital Kliniczny Dzieciatka Jezus

Warsaw, , Poland

Countries

Poland

Other Identifiers

OFA LSG

Identifier Type: -

Identifier Source: org_study_id