A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
Overview
- Phase
- Phase 3
- Intervention
- Acetaminophen, Gabapentin
- Conditions
- Anesthesia
- Sponsor
- University of Saskatchewan
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time to first flatus
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Jonathan Gamble
Anesthesiologist
University of Saskatchewan
Eligibility 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)
Arms & Interventions
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Intervention: Acetaminophen, Gabapentin
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Intervention: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Intervention: Dexamethasone, Ondansetron
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
Intervention: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
Intervention: Acetaminophen, Gabapentin
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
Intervention: Dexamethasone, Ondansetron
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
Intervention: Lidocaine 1% Injectable Solution, Sufentanil
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
Intervention: Sevoflurane, Sufentanil
Outcomes
Primary Outcomes
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 Outcomes
- Quality of recovery after surgery(End of surgery to time of patient discharge from hospital (2-10 days))
- Time to tolerance of oral intake(End of surgery to first oral intake (1-3 days))
- 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))
- Time to first defecation(End of surgery to first defecation (1-7 days))
- Visual Analogue Scale (VAS) pain scores(End of surgery to 48 hours postoperatively)
- Total Post-Anesthetic Care Unit (PACU) opioid consumption(End of surgery to discharge from PACU (1-2 hours))