Clinical trial NCT03507634: Opioid Free Anesthesia in Bariatric Surgery
Official title: Opioid Free Anesthesia in Bariatric Surgery: A Prospective, Double-blinded, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Postoperative Pain
Postoperative Nausea and Vomiting
Bariatric Surgery Candidate
Keywords: Lidocaine
Dexmedetomidine
Opioid Free
Bariatric surgery
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: Postoperative pain score for 48 hours
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Postoperative morphine consumption at the PACU (Post Anesthesia Care Unit)
timeFrame: 2 hours postoperative
measure: Postoperative morphine consumption at the surgical ward for 48 hours
timeFrame: 48 hours postoperative
measure: Postoperative morphine Side effects: Sedation score .for 48 hours
timeFrame: 48 hours postoperative
measure: Postoperative morphine Side effects:Respiratory depression for 48 hours
timeFrame: 48 hours postoperative
measure: Postoperative morphine Side effects: Nausea vomiting for 48 hours
timeFrame: 48 hours postoperative
measure: Postoperative morphine Side effects: Itching for 48 hours
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: LAU Medical Center
Study officials:
References: