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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Bowel Diseases, Inflammatory, Bowel Surgery, Laparoscopic Abdominal Surgeries

In brief

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.

Key facts

Study ID: NCT07434310
Run by: Dr. Naveed Siddiqui
People needed: 70
Starts: 2026-07-01
Expected to finish: 2027-12-01
Last updated by the study team: 2026-06-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged 18-70 years.
Undergoing elective or semi-elective laparoscopic-assisted bowel surgery (e.g., bowel resection, colectomy, ileostomy reversal).
ASA physical status I-III.

You may not qualify if…

Known allergy or hypersensitivity to dexmedetomidine.
Cardiac impairment defined as:
Moderate or severe systolic dysfunction
Moderate or severe valvulopathy (as per American Society of Echocardiography criteria)
Significant bradycardia (baseline heart rate < 60) or
Heart block without a pacemaker.
Active infection or sepsis at the time of surgery.
Use of medications with significant interactions with dexmedetomidine (e.g., MAO inhibitors).
Pregnant or breastfeeding individuals.
Current opioid use (> 30 mg daily oral morphine equivalent) or history of opioid use disorder.
Current clonidine use.
Patients undergoing thoracic epidurals.
Patients with liver impairment with a Child-Pugh class of B (moderate) or C (severe).

Where it is running

Mount Sinai Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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