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

NCT07434310 | Not Yet Recruiting Phase 3

• 1 other identifier: 1308
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bowel surgery; pain after surgery; quality of recovery; recovery after surgery; laparoscopic surgery; postoperative pain; bowel surgery pain; laparoscopy surgery pain; abdominal pain; laparoscopy

Outcome Measures

Primary Outcomes (1)

• Quality of recovery: QoR-15 scores at 48 hours postoperatively.

  The primary outcome of the study is the Quality of Recovery (QoR-15) score at 48 hours following surgery. The QoR-15 is a validated 15-item questionnaire that assesses four key domains of postoperative recovery: physical comfort, emotional state, physical independence, and psychological support. In this questionnaire, values range from 0 to 150 where higher scores indicate better recovery and lower scores indicate poorer recovery. The decision to use QoR-15 as the primary outcome was informed in part based on patient feedback, as QoR-15 captures the patient's overall recovery experience rather than narrowly focusing on pain or opioid use. This provides a more patient-centered measure of analgesia effectiveness that aligns with modern perioperative analgesia research.

  Up to 7 days post-operatively

Secondary Outcomes (7)

• Quality of recovery: QoR-15 scores at 24, 72 hours, and 7 days postoperatively.

  Up to 7 days post-operatively

• 2. Opioid consumption (measured in morphine milligram equivalents) at 24, 48, and 72 hours, and 7 days postoperatively

  Up to 7 days post-operatively

• 3. Pain management: Pain scores assessed by Numeric Rating Scale (NRS) at 24, 48, 72 hours, and 7 days, postoperatively.

  Up to 7 days post-operatively

• Postoperative complications: Incidence of nausea, vomiting, ileus, pruritus, and sedation.

  Up to 7 days post-operatively

• Time to return of bowel function, defined as: time to first flatus, time to first bowel movement, time to tolerating oral regular or soft diet.

  Up to 7 days post-operatively

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine infusion

Placebo

PLACEBO COMPARATOR

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

Other: Postoperative matched placebo of 0.9% saline infusion

Interventions

Dexmedetomidine infusion DRUG

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

Dexmedetomidine

Postoperative matched placebo of 0.9% saline infusion OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dr. Naveed Siddiqui: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Pain, Postoperative; Abdominal Pain

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

Pedro M Eman, MD

CONTACT

416-586-4800; pedro.eman@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Anesthesia, Faculty of Medicine, University of Toronto

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 25, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)