Opioid Free Anesthesia Versus Opioid Based Anesthesia

Not Applicable

Not yet recruiting

• Conditions: Opioid Free Anesthesia; Laparoscopic Bariatric Surgeries
• Interventions: Drug: Fentanyl infusion; Drug: Dexamedomedine and ketamine infusion

• Registration Number: NCT06650371
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Study Start: 2024-11-20
• Primary Completion: 2025-05-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl infusion	Fentanyl infusion	Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).
Dexamedomedine and ketamine 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.

Primary Outcome Measures

Name	Time	Method
Time between the end of operation to PACU	15 minutes	Decrease opioid usage ,decrease recovery time
Time between the end of analgesic used and an Aldrete score > 9 (when applicable).	15 minutes	Decrease opioid usage ,decrease recovery time

Secondary Outcome Measures

Name	Time	Method
Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].	24 hours postoperative	number of episodes of nausea and vomiting postoperative
Cumulative pethidine consumption	24 hours postoperative	decrease the need to postoperative pethidine