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
1 other identifier
interventional
36
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedStudy Start
First participant enrolled
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedOctober 21, 2024
October 1, 2024
5 months
September 29, 2024
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Cumulative pethidine consumption
24 hours postoperative
Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].
24 hours postoperative
Study Arms (2)
Fentanyl infusion
ACTIVE COMPARATORAnalgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).
Dexamedomedine and ketamine infusion
ACTIVE COMPARATOROpioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW.
Interventions
opioid based anesthesia analgesia will be offered by fentanyl in induction and maintenance according to Ideal Body Weight (IBW).
Analgesia will be offered by syringe containing ketamine and Dexmedetomidine in induction and maintenance according to IBW.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
September 29, 2024
First Posted
October 21, 2024
Study Start
November 20, 2024
Primary Completion
May 1, 2025
Study Completion
August 1, 2025
Last Updated
October 21, 2024
Record last verified: 2024-10