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

Christine Oryhan

Status and phase: Completed; Phase 3

Conditions: Bariatric Surgery Candidate; Opioid Use, Unspecified; Anesthesia

Treatments: Drug: Non Opioid Analgesics; Drug: Opioid Anesthetics

Study type: Interventional

Funder types: Other

Identifiers

NCT04081545

CRP19060

Details and patient eligibility

About

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

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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181 participants in 2 patient groups

Control Goup A- Opioid-based regimen

Active Comparator group

Description:

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

Treatment:

Drug: Opioid Anesthetics

Experimental Group B- Opioid-free regimen

Experimental group

Description:

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

Treatment:

Drug: Non Opioid Analgesics