Opioid Free Anesthesia in Bariatric Surgery

NCT ID: NCT03507634

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2020-06-30

Brief Summary

This study compares the intraoperative opioid free anesthesia approach in laparoscopic bariatric surgery to a conventional opioid- based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

Detailed Description

Since optimal analgesia for the obese patients undergoing bariatric surgeries has always been challenging, and knowing the comorbidities and physiological changes in this population, use of opioid-sparing agents during anesthesia has attracted substantial research.the use of opioids in the perioperative period in obese patients is associated with an increased risk of complications . They are especially more sensitive to the respiratory depressant effect of opioids , thus any analgesic alternative without further compromising airway tone would be a desirable choice.

Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic and sedative properties, without compromising airway tone and reflexes .

Lidocaine, a local anesthetic that has been shown to be an effective multimodal strategy to minimize postoperative pain was evaluated in one study involving obese patients undergoing bariatric surgery. Its usage was associated with an improved quality of recovery compared to placebo .

Conditions

Opioid Use; Postoperative Pain; Postoperative Nausea and Vomiting; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Opioid Based Anesthesia

General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl and Sevoflurane.

Group Type: ACTIVE_COMPARATOR

Opioid based anesthesia Fentanyl and Remifentanyl

Intervention Type: DRUG

Opioid based anesthesia with Fentanyl and Remifentanyl

Opioid Free Anesthesia

General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine and Sevoflurane.

Group Type: ACTIVE_COMPARATOR

Opioid free Anesthesia dexmedetomidine and lidocaine

Intervention Type: DRUG

Opioid free anesthesia with dexmedetomidine and lidocaine

Interventions

Opioid free Anesthesia dexmedetomidine and lidocaine

Opioid free anesthesia with dexmedetomidine and lidocaine

Intervention Type: DRUG

Opioid based anesthesia Fentanyl and Remifentanyl

Opioid based anesthesia with Fentanyl and Remifentanyl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age group: 18-65 years old
• American Society of Anesthesiologists (ASA )class I and II
• Indicated laparoscopic bariatric surgery

Exclusion Criteria

• Renal, hepatic or cardiac insufficiency
• Positive pregnancy test
• Alcohol or drug abuse
• Psychiatric disease
• History of chronic pain
• Allergy or contraindication to any of the study drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lebanese American University

OTHER

Sponsor Role: lead

Responsible Party

Hanane Barakat

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

LAU Medical Center

Beirut, , Lebanon

Countries

Lebanon

References

Barakat H, Gholmieh L, Nader JA, Karam VY, Albaini O, Helou ME, Al Nawwar R. Opioid-free versus opioid-based anesthesia in laparoscopic sleeve gastrectomy: a single-center, randomized, controlled trial. Perioper Med (Lond). 2025 Feb 5;14(1):16. doi: 10.1186/s13741-024-00486-5.

Reference Type: DERIVED

PMID: 39910664 (View on PubMed)

Other Identifiers

LAUMCRH.HB2.28/Mar/2018

Identifier Type: -

Identifier Source: org_study_id