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

NCT ID: NCT04144933

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2024-08-01

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.

Conditions

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

Keywords

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Opioid-free Opioid-sparing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Opioid-free General Anesthesia (OFA)

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

Group Type EXPERIMENTAL

Acetaminophen, Gabapentin

Intervention Type DRUG

975 mg, 300 mg

Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine

Intervention Type DRUG

1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg

Dexamethasone, Ondansetron

Intervention Type DRUG

6 mg, 4 mg

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

Intervention Type DRUG

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

Traditional Opioid-containing General Anesthesia (TOA)

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

Group Type ACTIVE_COMPARATOR

Acetaminophen, Gabapentin

Intervention Type DRUG

975 mg, 300 mg

Dexamethasone, Ondansetron

Intervention Type DRUG

6 mg, 4 mg

Lidocaine 1% Injectable Solution, Sufentanil

Intervention Type DRUG

0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)

Sevoflurane, Sufentanil

Intervention Type DRUG

Dose titrated to effect, As needed (dose at anesthesiologist's discretion)

Interventions

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Acetaminophen, Gabapentin

975 mg, 300 mg

Intervention Type DRUG

Acetaminophen, Gabapentin

975 mg, 300 mg

Intervention Type DRUG

Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine

1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg

Intervention Type DRUG

Dexamethasone, Ondansetron

6 mg, 4 mg

Intervention Type DRUG

Sevoflurane, 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

Intervention Type DRUG

Lidocaine 1% Injectable Solution, Sufentanil

0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)

Intervention Type DRUG

Sevoflurane, Sufentanil

Dose titrated to effect, As needed (dose at anesthesiologist's discretion)

Intervention Type DRUG

Other Intervention Names

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Opioid-free preoperative medications Opioid-containing preoperative medications Opioid-free pre-intubation medications Postoperative nausea and vomiting prophylaxis Opioid-free maintenance medications Opioid-containing pre-intubation medications Opioid-containing maintenance medications

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Gamble

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jonathan Gamble, MD

Role: CONTACT

Phone: 306-655-1183

Email: [email protected]

Facility Contacts

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Jennifer O'Brien, PhD

Role: primary

Other Identifiers

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BIO-625

Identifier Type: -

Identifier Source: org_study_id