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

Ketamine

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.

Intervention / Treatment

  • Acetaminophen, Gabapentin (DRUG)
    975 mg, 300 mg
  • Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine (DRUG)
    1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
  • Dexamethasone, Ondansetron (DRUG)
    6 mg, 4 mg
  • 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
  • Lidocaine 1% Injectable Solution, Sufentanil (DRUG)
    0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
  • Sevoflurane, Sufentanil (DRUG)
    Dose titrated to effect, As needed (dose at anesthesiologist's discretion)

Condition or Disease

  • Anesthesia
  • General Anesthesia
  • Analgesics, Opioid
  • Opioid Free Anesthesia
  • Postoperative Ileus
  • Colorectal Surgery
  • Laparoscopic Surgery
  • Analgesia
  • Dexmedetomidine
  • Lidocaine
  • Ketamine

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 15, 2021 ACTUAL
    Primary Completion: Jul 30, 2023 ESTIMATED
    Completion Date: Jan 01, 2024 ESTIMATED
    Study First Posted: Oct 30, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 31, 2022

    Sponsors / Collaborators

    Lead Sponsor: University of Saskatchewan
    Responsible Party: N/A

    Location

    Saskatoon, Saskatchewan, Canada

    The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.

    Participant Groups

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

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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

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

    Secondary Outcomes

    • Time between the end of surgery and the moment the patient first passes stool

    • Time between the end of surgery to when the patient can tolerate any oral solid food intake

    • Total amount of opioid (morphine equivalents) required in PACU

    • Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively

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

    • Visual Analogue Scale (VAS) pain scores will be recorded on a scale of 0 to 10, with 0 indicating no pain, and 10 indicating extreme pain, 48 hours following surgery

    • Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery

    More Details

    NCT Number: NCT04144933
    Acronym: RUMBLE
    Other IDs: BIO-625
    Study URL: https://clinicaltrials.gov/study/NCT04144933
    Last updated: Sep 29, 2023