Opioid Free Anesthesia in Bariatric Surgery

Lebanese American University

Status: Completed

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

Treatments: Drug: Opioid free Anesthesia dexmedetomidine and lidocaine; Drug: Opioid based anesthesia Fentanyl and Remifentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03507634

LAUMCRH.HB2.28/Mar/2018

Details and patient eligibility

About

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

Full 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 .

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups

Opioid Based Anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Opioid based anesthesia Fentanyl and Remifentanyl

Opioid Free Anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Opioid free Anesthesia dexmedetomidine and lidocaine