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Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

NCT04260659 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-03-08

No results posted yet for this study

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.

Conditions

  • Obesity
  • Postoperative Pain
  • Postoperative Nausea
  • Postoperative Vomiting
  • Opioid 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.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Piotr Mieszczański, MD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2022-10-06
Completion
2023-02-22

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04260659 on ClinicalTrials.gov