Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery

NCT04144933 | Unknown Phase 3

• 1 other identifier: BIO-625
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; Colorectal Surgery; Laparoscopic Surgery; Analgesia; Dexmedetomidine; Lidocaine; Ketamine

Keywords

Opioid-free; Opioid-sparing

Outcome Measures

Primary Outcomes (1)

• Time to first flatus

  Time between the end of surgery and the movement when the patient first passes flatus

  End of surgery to first flatus (1-4 days)

Secondary Outcomes (7)

• Time to first defecation

  End of surgery to first defecation (1-7 days)

• Time to tolerance of oral intake

  End of surgery to first oral intake (1-3 days)

• Total Post-Anesthetic Care Unit (PACU) opioid consumption

  End of surgery to discharge from PACU (1-2 hours)

• Patient Controlled Analgesia (PCA) morphine consumption

  End of surgery to 48 hours postoperatively

• Time to Post-Anesthetic Care Unit (PACU) discharge readiness

  End of surgery to PACU discharge readiness (1-3 hours)

Study Arms (2)

Opioid-free General Anesthesia (OFA)

EXPERIMENTAL

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

Drug: Acetaminophen, Gabapentin; Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine; Drug: Dexamethasone, Ondansetron; Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate

Traditional Opioid-containing General Anesthesia (TOA)

ACTIVE COMPARATOR

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

Drug: Acetaminophen, Gabapentin; Drug: Dexamethasone, Ondansetron; Drug: Lidocaine 1% Injectable Solution, Sufentanil; Drug: Sevoflurane, Sufentanil

Interventions

Acetaminophen, Gabapentin DRUG

975 mg, 300 mg

Also known as: Opioid-free preoperative medications

Opioid-free General Anesthesia (OFA)

Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine DRUG

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

Also known as: Opioid-free pre-intubation medications

Opioid-free General Anesthesia (OFA)

Dexamethasone, Ondansetron DRUG

6 mg, 4 mg

Also known as: Postoperative nausea and vomiting prophylaxis

Opioid-free General Anesthesia (OFA); Traditional Opioid-containing General Anesthesia (TOA)

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

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

Also known as: Opioid-free maintenance medications

Opioid-free General Anesthesia (OFA)

Lidocaine 1% Injectable Solution, Sufentanil DRUG

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

Also known as: Opioid-containing pre-intubation medications

Traditional Opioid-containing General Anesthesia (TOA)

Sevoflurane, Sufentanil DRUG

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

Also known as: Opioid-containing maintenance medications

Traditional Opioid-containing General Anesthesia (TOA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen; Gabapentin; Lidocaine; Dexmedetomidine; Ketamine; Dexamethasone; Ondansetron; Sevoflurane; Magnesium Sulfate; Sufentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Fentanyl; Piperidines

Central Study Contacts

Jonathan Gamble, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 30, 2019
• Study Start: May 15, 2021
• Primary Completion: July 30, 2024
• Study Completion: August 1, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)