Clinical trial NCT04081545: Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery
Official title: The Effect of an Opioid-free Anesthetic on Post-operative Opioid Consumption After Laparoscopic Bariatric Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Use, Unspecified
Bariatric Surgery Candidate
Anesthesia
Keywords: Opioid Free Anesthesia
Bariatric Surgery
Non-Opioid Anesthesia
Ketamine
Dexmedetomidine
Lidocaine
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
First posted: 2019-09-09
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators plan to enroll 196 subjects at Virginia Mason Medical Center that are undergoing laparoscopic bariatric surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm, with a computer generated arm assignment. Subjects will be blinded to the assigned arm. Group A will receive a traditional opioid restrictive general anesthetic and group B will receive an opioid-free anesthetic technique.
Primary purpose: OTHER

Brief summary: A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.

Detailed description: This is a prospective, single-center, single-blinded, randomized controlled trial comparing the effect of an opioid-free general anesthetic versus a traditional anesthetic with a restricted quantity of opioid on postoperative opioid consumption following laparoscopic bariatric surgery. The study population will be composed of 196 subjects undergoing laparoscopic bariatric surgery at Virginia Mason Medical center randomized into two groups. The control group will receive a traditional opioid restrictive general anesthetic. The study group will receive an opioid-free anesthetic technique.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent

Exclusion Criteria:

* Any opioid use within 4 weeks prior to surgery
* Chronic antiemetic use
* Conversion of laparoscopic to open surgery
* Patients unable to provide post-operative pain scores
* Pregnant or lactating patients
* Patients under 18 years of age
* Refusal or inability to provide informed consent

Primary outcomes:
measure: 24 Hour Opioid Consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Length of Time Under General Anesthesia
timeFrame: 1-5 hours
measure: Percentage of Patients With Opioid-related Adverse Effects
timeFrame: 24 hours
measure: Length of Time to Recover From General Anesthesia
timeFrame: 1-3 hours
measure: Length of Hospital Stay
timeFrame: 1-5 days
measure: Overall Patient Satisfaction With Analgesia: Yes or no
timeFrame: 24 hours
measure: Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days
timeFrame: 30 days
measure: Percentage of Patients Treated for General Anesthetic Adverse Effects
timeFrame: Intraoperative, between time entering OR and PACU arrival time
measure: Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Christine Oryhan, MD
role: PRINCIPAL_INVESTIGATOR
References: