Analgesia, Analgesics, Opioid, Anesthesia, Colorectal Surgery, Dexmedetomidine, General Anesthesia, Ketamine, Laparoscopic Surgery, Lidocaine, Opioid Free Anesthesia, Postoperative Ileus
Conditions
Keywords
Opioid-free, Opioid-sparing
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.
Interventions
975 mg, 300 mg
DRUGLidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine
1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
6 mg, 4 mg
DRUGSevoflurane, 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
DRUGLidocaine 1% Injectable Solution, Sufentanil
0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
DRUGSevoflurane, Sufentanil
Dose titrated to effect, As needed (dose at anesthesiologist's discretion)
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 |
| 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 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 |
Countries
Canada
Contacts
Primary ContactJonathan Gamble, MD
Outcome results
None listed