Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery

NCT04081545 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CRP19060
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Use, Unspecified; Bariatric Surgery Candidate; Anesthesia

Keywords

Opioid Free Anesthesia; Bariatric Surgery; Non-Opioid Anesthesia; Ketamine; Dexmedetomidine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 24 Hour Opioid Consumption

  Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses

  24 hours

Secondary Outcomes (8)

• Length of Time Under General Anesthesia

  1-5 hours

• Percentage of Patients With Opioid-related Adverse Effects

  24 hours

• Length of Time to Recover From General Anesthesia

  1-3 hours

• Length of Hospital Stay

  1-5 days

• Overall Patient Satisfaction With Analgesia: Yes or no

  24 hours

Study Arms (2)

Control Goup A- Opioid-based regimen

ACTIVE COMPARATOR

Preop - Multimodals unless contraindicated Induction * Fentanyl (50mcg IV) * Lidocaine 1.5mg/kg IV bolus using IBW (Ideal body weight) * Propofol 2-3mg/kg IV bolus * Neuromuscular blockade per Anesthesiology team discretion Maintenance * Sevoflurane * Neuromuscular blockade at discretion of anesthesiology team * May use fentanyl to treat SBP or HR \> 20% of baseline Emergence * Neuromuscular reversal, dosed according to Virginia Mason protocol * May titrate fentanyl per anesthesiology team throughout the case. * Patient extubated and brought to PACU PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch

Drug: Opioid Anesthetics

Experimental Group B- Opioid-free regimen

EXPERIMENTAL

Preop - Multimodals unless contraindicated Induction * Dexmedetomidine 1mcg/kg IV bolus over 10 minutes using IBW * Lidocaine 1.5mg/kg IV bolus using IBW * Propofol 2-3mg/kg IV bolus * Neuromuscular blockade per Anesthesiology team discretion * Ketamine 0.5mg/kg IV bolus (based on IBW) Maintenance * Sevoflurane * Dexmedetomidine 0.4 mcg/kg/hr IV infusion using IBW (may titrate based on patient response between 0.3-0.5mcg/kg/hr) * Lidocaine 2mg/kg/hr IV infusion using IBW * May use esmolol as needed to treat SBP or HR \> 20% of baseline * Neuromuscular blockade at the discretion of anesthesiology team Emergence * Dexmedetomidine infusion turned off during laparoscopic desufflation * Lidocaine infusion turned off at skin closure * Neuromuscular reversal, dosed according to VM protocol * Pt extubated and brought to PACU * PACU opioid orders per anesthesiology team Post-operative Nausea/Vomiting Prophylaxis -4mg dexamethasone, 1mg haloperidol, scopolamine patch

Drug: Non Opioid Analgesics

Interventions

Opioid Anesthetics DRUG

see arm/group description

Also known as: Opioid-based regimen

Control Goup A- Opioid-based regimen

Non Opioid Analgesics DRUG

see arm/group description

Also known as: Opioid-free regimen

Experimental Group B- Opioid-free regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christine Oryhan: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Interventions

Analgesics, Non-Narcotic

Intervention Hierarchy (Ancestors)

Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Christine Oryhan
• Organization: Virginia Mason Medical Center

christine.oryhan@virginiamason.org

206-223-6980

Study Officials

• Christine Oryhan, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist and Pain Medicine Physician

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 9, 2019
• Study Start: December 24, 2019
• Primary Completion: March 29, 2023
• Study Completion: June 30, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)