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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144933
Recruitment Status : Not yet recruiting
First Posted : October 30, 2019
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Gamble, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Anesthesia General Anesthesia Analgesics, Opioid Opioid Free Anesthesia Postoperative Ileus Colorectal Surgery Laparoscopic Surgery Analgesia Dexmedetomidine Lidocaine Ketamine Drug: Acetaminophen, Gabapentin Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine Drug: Dexamethasone, Ondansetron Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate Drug: Lidocaine 1% Injectable Solution, Sufentanil Drug: Sevoflurane, Sufentanil Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Drug: Acetaminophen, Gabapentin
975 mg, 300 mg
Other Name: Opioid-free preoperative medications

Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine
1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
Other Name: Opioid-free pre-intubation medications

Drug: Dexamethasone, Ondansetron
6 mg, 4 mg
Other Name: Postoperative nausea and vomiting prophylaxis

Drug: 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
Other Name: Opioid-free maintenance medications

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.
Drug: Acetaminophen, Gabapentin
975 mg, 300 mg
Other Name: Opioid-containing preoperative medications

Drug: Dexamethasone, Ondansetron
6 mg, 4 mg
Other Name: Postoperative nausea and vomiting prophylaxis

Drug: Lidocaine 1% Injectable Solution, Sufentanil
0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
Other Name: Opioid-containing pre-intubation medications

Drug: Sevoflurane, Sufentanil
Dose titrated to effect, As needed (dose at anesthesiologist's discretion)
Other Name: Opioid-containing maintenance medications




Primary Outcome Measures :
  1. Time to first flatus [ Time Frame: End of surgery to first flatus (1-4 days) ]
    Time between the end of surgery and the movement when the patient first passes flatus


Secondary Outcome Measures :
  1. Time to first defecation [ Time Frame: End of surgery to first defecation (1-7 days) ]
    Time between the end of surgery and the moment the patient first passes stool

  2. Time to tolerance of oral intake [ Time Frame: End of surgery to first oral intake (1-3 days) ]
    Time between the end of surgery to when the patient can tolerate any oral solid food intake

  3. Total Post-Anesthetic Care Unit (PACU) opioid consumption [ Time Frame: End of surgery to discharge from PACU (1-2 hours) ]
    Total amount of opioid (morphine equivalents) required in PACU

  4. Patient Controlled Analgesia (PCA) morphine consumption [ Time Frame: End of surgery to 48 hours postoperatively ]
    Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively

  5. Time to Post-Anesthetic Care Unit (PACU) discharge readiness [ Time Frame: End of surgery to PACU discharge readiness (1-3 hours) ]
    Time to Post-Anesthetic Care Unit (PACU) discharge readiness

  6. Visual Analogue Scale (VAS) pain scores [ Time Frame: End of surgery to 48 hours postoperatively ]
    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

  7. Quality of recovery after surgery [ Time Frame: End of surgery to time of patient discharge from hospital (2-10 days) ]
    Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144933


Contacts
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Contact: Jonathan Gamble, MD 306-655-1183 jonathan.gamble@saskhealthauthority.ca

Locations
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Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Jennifer O'Brien, PhD    306-655-6497    jennifer.o'brien@saskatoonhealthregion.ca   
Sponsors and Collaborators
University of Saskatchewan

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Responsible Party: Jonathan Gamble, Anesthesiologist, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04144933    
Other Study ID Numbers: BIO-625
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Gamble, University of Saskatchewan:
Opioid-free
Opioid-sparing
Additional relevant MeSH terms:
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Acetaminophen
Dexamethasone
Lidocaine
Magnesium Sulfate
Sufentanil
Dexmedetomidine
Ketamine
Gabapentin
Analgesics, Opioid
Ondansetron
Sevoflurane
Pharmaceutical Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers