Use of Dexmedetomidine to Improve Pain Control and Recovery After Laparocopic-Assisted Bowel Surgery in Adults

Summary

This study is testing whether continuing a medication called dexmedetomidine after surgery can improve quality of recovery for adults undergoing laparoscopic-assisted bowel surgery.

After bowel surgery, many patients experience significant pain and slow recovery. Pain is often treated with strong opioid medications, which can cause side effects such as nausea, vomiting, constipation, sedation, and delayed return of bowel function. Other pain control options, such as epidurals or nerve blocks, are not always suitable for laparoscopic bowel surgery and may have their own risks or limitations. As a result, there are few effective non-opioid options for managing pain in this patient group.

Dexmedetomidine is a medication that can reduce pain and the need for opioids while providing sedation without affecting breathing. It is commonly used during surgery, but it is not known whether continuing dexmedetomidine after surgery improves pain control and overall recovery in bowel surgery patients. This study aims to answer that question.

The PODEX study is a single-centre, randomized, double-blind, placebo-controlled trial. Adults aged 18 to 70 years who are having elective or semi-elective laparoscopic-assisted bowel surgery will be invited to take part. About 94 participants will be enrolled. After surgery, participants will be randomly assigned (by chance) to receive either a continuous dexmedetomidine infusion or a placebo (salt water) infusion for 48 hours. Neither the participants nor the study team will know which treatment a participant receives during the study. All participants will receive the same standard surgical care, anesthesia, and postoperative pain medications.

The main outcome of the study is quality of recovery, measured 48 hours after surgery using a short questionnaire (QoR-15) that asks about comfort, pain, physical well-being, and emotional state. Other outcomes include recovery scores at additional time points, pain levels, opioid use, nausea and vomiting, return of bowel function, length of hospital stay, and side effects such as low blood pressure or slow heart rate.

The results of this study may help determine whether postoperative dexmedetomidine is a safe and effective way to improve recovery and reduce opioid use after bowel surgery.

Conditions

• Bowel Diseases, Inflammatory
• Bowel Surgery
• Laparoscopic Abdominal Surgeries

Interventions

DRUG

Dexmedetomidine infusion

Postoperative dexmedetomidine infusion 400 mcg in 100 mL at a rate of 0.15 mcg/kg/h for a total of 48 hours via a continuous ambulatory delivery device (CADD) pump

OTHER

Postoperative matched placebo of 0.9% saline infusion

Arm Description: Postoperative matched placebo of 0.9% saline infusion for a total of 48 hours via a continuous ambulatory delivery device (CADD) pump

Sponsors & Collaborators

• Mount Sinai Hospital, Canada

  collaborator OTHER

• Dr. Naveed Siddiqui

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2027-07-01

Completion

2027-12-01

Countries

• Canada

Study Locations