Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
- Conditions
- Colorectal SurgeryKetamineAnalgesics, OpioidAnesthesiaGeneral AnesthesiaOpioid Free AnesthesiaLaparoscopic SurgeryAnalgesiaPostoperative IleusDexmedetomidine
- Interventions
- Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium SulfateDrug: Sevoflurane, Sufentanil
- Registration Number
- NCT04144933
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional Opioid-containing General Anesthesia (TOA) Acetaminophen, Gabapentin Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. Traditional Opioid-containing General Anesthesia (TOA) Dexamethasone, Ondansetron Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. Opioid-free General Anesthesia (OFA) Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. Opioid-free General Anesthesia (OFA) Dexamethasone, Ondansetron Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. Opioid-free General Anesthesia (OFA) Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. Traditional Opioid-containing General Anesthesia (TOA) Lidocaine 1% Injectable Solution, Sufentanil Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. Traditional Opioid-containing General Anesthesia (TOA) Sevoflurane, Sufentanil Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. Opioid-free General Anesthesia (OFA) Acetaminophen, Gabapentin Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
- Primary Outcome Measures
Name Time Method Time to first flatus 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
Name Time Method Quality of recovery after surgery 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
Time to tolerance of oral intake 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
Patient Controlled Analgesia (PCA) morphine consumption End of surgery to 48 hours postoperatively Total amount of PCA morphine (mg) required from 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 Post-Anesthetic Care Unit (PACU) discharge readiness
Time to first defecation End of surgery to first defecation (1-7 days) Time between the end of surgery and the moment the patient first passes stool
Visual Analogue Scale (VAS) pain scores 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
Total Post-Anesthetic Care Unit (PACU) opioid consumption End of surgery to discharge from PACU (1-2 hours) Total amount of opioid (morphine equivalents) required in PACU
Trial Locations
- Locations (1)
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada