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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery

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

Intervention / Treatment
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* Drug: Acetaminophen, Gabapentin
* 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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid-free General Anesthesia (OFA)<br>Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. | Drug: Acetaminophen, Gabapentin<br>* 975 mg, 300 mg<br>* Other names: Opioid-free preoperative medications;Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine<br>* 1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg<br>* Other names: Opioid-free pre-intubation medications;Drug: Dexamethasone, Ondansetron<br>* 6 mg, 4 mg<br>* Other names: Postoperative nausea and vomiting prophylaxis;Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate<br>* 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<br>* Other names: Opioid-free maintenance medications;|
| Active Comparator: Traditional Opioid-containing General Anesthesia (TOA)<br>Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. | Drug: Acetaminophen, Gabapentin<br>* 975 mg, 300 mg<br>* Other names: Opioid-containing preoperative medications;Drug: Dexamethasone, Ondansetron<br>* 6 mg, 4 mg<br>* Other names: Postoperative nausea and vomiting prophylaxis;Drug: Lidocaine 1% Injectable Solution, Sufentanil<br>* 0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)<br>* Other names: Opioid-containing pre-intubation medications;Drug: Sevoflurane, Sufentanil<br>* Dose titrated to effect, As needed (dose at anesthesiologist's discretion)<br>* Other names: Opioid-containing maintenance medications;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first flatus | Time between the end of surgery and the movement when the patient first passes flatus | End of surgery to first flatus (1-4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first defecation | Time between the end of surgery and the moment the patient first passes stool | End of surgery to first defecation (1-7 days) | 
| Time to tolerance of oral intake | Time between the end of surgery to when the patient can tolerate any oral solid food intake | End of surgery to first oral intake (1-3 days) | 
| Total Post-Anesthetic Care Unit (PACU) opioid consumption | Total amount of opioid (morphine equivalents) required in PACU | End of surgery to discharge from PACU (1-2 hours) | 
| Patient Controlled Analgesia (PCA) morphine consumption | Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively | End of surgery to 48 hours postoperatively | 
| Time to Post-Anesthetic Care Unit (PACU) discharge readiness | Time to Post-Anesthetic Care Unit (PACU) discharge readiness | End of surgery to PACU discharge readiness (1-3 hours) | 
| Visual Analogue Scale (VAS) pain scores | 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 | End of surgery to 48 hours postoperatively | 
| Quality of recovery after surgery | Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery | End of surgery to time of patient discharge from hospital (2-10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid-free, Opioid-sparing