Opioid Free Anesthesia Versus Opioid Based Anesthesia

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Free Anesthesia; Laparoscopic Bariatric Surgeries
• Intervention / Treatment: Drug: Fentanyl infusion; Drug: Dexamedomedine and ketamine infusion

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman Mohamed Zain; Phone Number: 01017254024; Email: emanzain@med.asu.edu.eg
• Study Contact Backup: Name: Eman Zain; Phone Number: 01017254024

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl infusion; Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).	Drug: Fentanyl infusion; opioid based anesthesia analgesia will be offered by fentanyl in induction and maintenance according to Ideal Body Weight (IBW).
Active Comparator: Dexamedomedine and ketamine infusion; Opioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW.	Drug: Dexamedomedine and ketamine infusion; Analgesia will be offered by syringe containing ketamine and Dexmedetomidine in induction and maintenance according to IBW.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 29, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Opioid free anesthesia; laparoscopic bariatric surgeries
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ketamine; Fentanyl
• Other Study ID Numbers: FMASU MD126/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes