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

University of Saskatchewan

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: Acetaminophen, Gabapentin; Drug: Lidocaine 1% Injectable Solution, Sufentanil; Drug: Sevoflurane, Sufentanil; Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate; Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine; Drug: Dexamethasone, Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT04144933

BIO-625

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Opioid-free General Anesthesia (OFA)

Experimental group

Description:

Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.

Treatment:

Drug: Dexamethasone, Ondansetron

Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate

Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine

Drug: Acetaminophen, Gabapentin

Drug: Acetaminophen, Gabapentin

Traditional Opioid-containing General Anesthesia (TOA)

Active Comparator group

Description:

Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.

Treatment:

Drug: Dexamethasone, Ondansetron

Drug: Acetaminophen, Gabapentin

Drug: Sevoflurane, Sufentanil

Drug: Lidocaine 1% Injectable Solution, Sufentanil

Drug: Acetaminophen, Gabapentin