Recruiting
Phase 3

Opioid-free Anesthesia

Sponsor:

University of Saskatchewan

Code:

NCT04144933

Conditions

Anesthesia

General Anesthesia

Analgesics, Opioid

Opioid Free Anesthesia

Postoperative Ileus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen, Gabapentin

Acetaminophen, Gabapentin

Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine

Dexamethasone, Ondansetron

Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate

Study Details

Brief summary:

The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.

Conditions

Anesthesia

General Anesthesia

Analgesics, Opioid

Opioid Free Anesthesia

Postoperative Ileus

Study ID

NCT04144933

Start date

May 15, 2021

Status verified date

Dec, 2023

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery

Exclusion Criteria:

  • Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age < 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Opioid-free General Anesthesia (OFA)

Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.

active comparator: Traditional Opioid-containing General Anesthesia (TOA)

Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.

Interventions

Acetaminophen, Gabapentin

975 mg, 300 mg

Acetaminophen, Gabapentin

975 mg, 300 mg

Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine

1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg

Dexamethasone, Ondansetron

6 mg, 4 mg

Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate

Dose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes

Lidocaine 1% Injectable Solution, Sufentanil

0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)

Sevoflurane, Sufentanil

Dose titrated to effect, As needed (dose at anesthesiologist's discretion)

Primary outcome measure

  • Time to first flatus [ Time Frame: End of surgery to first flatus (1-4 days) ]

Central Contacts and Locations

Central contacts

Jonathan Gamble, MD

306-655-1183jonathan.gamble@saskhealthauthority.ca

Locations

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 0W8

Contacts

Jennifer O'Brien, PhD

306-655-6497jennifer.o'brien@saskatoonhealthregion.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

Dec 20, 2023

Last verified

Dec, 2023

Keywords

  • Opioid-free
  • Opioid-sparing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2023-12-20.