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Clinical Trials/NCT06650371
NCT06650371
Not yet recruiting
Not Applicable

Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries

Ain Shams University0 sites36 target enrollmentNovember 20, 2024

Overview

Phase
Not Applicable
Intervention
Fentanyl infusion
Conditions
Opioid Free Anesthesia
Sponsor
Ain Shams University
Enrollment
36
Primary Endpoint
Time between the end of analgesic used and an Aldrete score > 9 (when applicable).
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV).

Detailed Description

While opioids have been commonly used in the operating room due to their effectiveness in pain management and anesthesia, there are numerous common side effects that have an impact on patient recovery. Obese patients or those with pre-existing respiratory difficulties such as sleep apnea or chronic obstructive pulmonary disease are more likely to experience respiratory failure after getting opiate therapy. Other effects of opioid use include gastro-intestinal obstacles such nausea, vomiting, and constipation. The concept of opioid-free anesthesia evolved due to the potential adverse side effects associated with intraoperative opioid usage. This study examines nociceptive monitoring's potential role in opioid-free anesthesia, as well as research on the topic. This study aims to compare the effects of an opioid-free anesthesia (OFA) regimen versus an opioid-based anesthesia (OBA) regimen on postoperative pain and enhanced recovery in patients undergoing bariatric surgery.

Registry
clinicaltrials.gov
Start Date
November 20, 2024
End Date
August 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eman Mohamed Zain Eldeen

Doctor

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia.
  • Age group: 18-65 years old.
  • BMI greater than 35 to 50 Kg/m2
  • ASA physical status classes I and II.

Exclusion Criteria

  • Patient refusal.
  • ASA physical status classes III and IV.
  • Anticipated difficult intubation.
  • Hypersensitivity to any drugs used in this study. Inability to extubate the patient at the end of the operation. Conversion to laparotomy. Patients for whom the anesthetic regimen is changed intraoperatively (from OFA to OBA or vice versa).

Arms & Interventions

Fentanyl infusion

Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).

Intervention: Fentanyl infusion

Dexamedomedine and ketamine infusion

Opioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW.

Intervention: Dexamedomedine and ketamine infusion

Outcomes

Primary Outcomes

Time between the end of analgesic used and an Aldrete score > 9 (when applicable).

Time Frame: 15 minutes

Decrease opioid usage ,decrease recovery time

Time between the end of operation to PACU

Time Frame: 15 minutes

Decrease opioid usage ,decrease recovery time

Secondary Outcomes

  • Cumulative pethidine consumption(24 hours postoperative)
  • Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].(24 hours postoperative)

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