Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Ketamine

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.

Intervention / Treatment

  • Drug: Dexmedetomidine Hydrochloride [Dexdor]
  • Drug: Remifentanil [Ultiva]
  • Drug: Ketamine [Ketalar]
  • Drug: Lidocaine [Xylocaine 2%]
  • Drug: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]
  • Drug: Fentanyl [Fentanyl WZF]

Condition or Disease

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

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 60 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Feb 04, 2020
Primary Completion: Feb 04, 2021
Completion Date: Feb 22, 2021
Study First Posted: Feb 07, 2020
Results First Posted: Aug 31, 2020
Last Updated: Mar 03, 2020

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Warsaw, Poland
Szpital Kliniczny Dzieciatka Jezus, Warsaw, Poland

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.

Eligibility Criteria

Sex: All
Minimum Age: 18

This clinical trial is recruiting

Are you interested in participating in this trial or others? We'd love to help.

More Details

NCT Number: NCT04260659
Other IDs: OFA LSG
Study URL: https://ClinicalTrials.gov/show/NCT04260659
Last updated: Jan 27, 2021