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

Postoperative Dexmedetomidine (PODEX) for Enhanced Recovery in Bowel Surgery: A Double-Blinded, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bowel Diseases, Inflammatory; Bowel Surgery; Laparoscopic Abdominal Surgeries
• Intervention / Treatment: Drug: Dexmedetomidine infusion; Other: Postoperative matched placebo of 0.9% saline infusion

Detailed Description

Postoperative pain control and recovery following bowel surgery remain significant clinical challenges. Although laparoscopic-assisted techniques have reduced surgical trauma compared with open procedures, many patients still experience substantial postoperative pain, delayed return of bowel function, opioid-related adverse effects, and prolonged hospitalization. These factors negatively affect patient-centered recovery outcomes and increase healthcare utilization.

Opioids remain a central component of postoperative analgesia after bowel surgery. However, opioid-based pain management is associated with well-recognized adverse effects, including nausea, vomiting, ileus, sedation, pruritus, respiratory depression, and the risk of persistent opioid use. In patients undergoing bowel surgery, these adverse effects are particularly problematic because impaired gastrointestinal motility can delay recovery and discharge. While multimodal analgesia strategies aim to reduce opioid exposure, commonly used alternatives such as nonsteroidal anti-inflammatory drugs (NSAIDs) are often contraindicated in this population, and regional anesthesia techniques (e.g., epidural analgesia or transversus abdominis plane blocks) are technically demanding, resource intensive, and not routinely used for laparoscopic-assisted procedures.

Dexmedetomidine is a selective α2-adrenergic receptor agonist with analgesic, sedative, and sympatholytic properties. Its mechanism of action includes modulation of nociceptive signaling in the spinal cord and central nervous system, reduction of sympathetic outflow, and attenuation of stress responses without clinically significant respiratory depression. Intraoperative dexmedetomidine has been shown to reduce postoperative pain scores, decrease opioid requirements, improve hemodynamic stability, and reduce postoperative nausea and vomiting in a variety of surgical populations, including abdominal surgery. Meta-analyses have also demonstrated improved recovery of bowel function associated with intraoperative dexmedetomidine use.

Despite these findings, existing studies have largely focused on intraoperative administration, and there is limited evidence regarding the potential benefits of continued dexmedetomidine infusion in the postoperative period, particularly in patients undergoing bowel surgery. This represents an important knowledge gap, as the immediate postoperative phase is when opioid exposure is highest and recovery trajectories are established. Dexmedetomidine's opioid-sparing effects, favorable sedation profile, and potential to facilitate gastrointestinal recovery suggest it may be well suited for postoperative use in this population.

The PODEX study was designed to evaluate whether a continued postoperative dexmedetomidine infusion improves recovery outcomes following laparoscopic-assisted bowel surgery. The study is a single-center, randomized, double-blind, placebo-controlled clinical trial conducted at Mount Sinai Hospital. Participants are adults undergoing elective or semi-elective laparoscopic-assisted bowel surgery who receive standardized perioperative care. All participants receive dexmedetomidine intraoperatively as part of routine anesthetic management, ensuring that the study specifically evaluates the incremental benefit of postoperative continuation of dexmedetomidine rather than its initiation during surgery.

Following surgery, participants are randomized to receive either dexmedetomidine or a matched placebo administered as a continuous intravenous infusion for up to 48 hours using a continuous ambulatory delivery device. The selected infusion rate reflects prior evidence demonstrating efficacy for analgesia and gastrointestinal recovery while minimizing risks of hypotension, bradycardia, and excessive sedation, making it appropriate for use on a surgical ward rather than an intensive care setting.

The study emphasizes patient-centered recovery using validated instruments rather than relying solely on traditional clinical endpoints. Recovery is assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a multidimensional, patient-reported outcome measure that captures physical comfort, pain, emotional well-being, psychological support, and functional independence. Additional assessments evaluate pain intensity, opioid consumption, gastrointestinal recovery, length of hospital stay, and postoperative complications. Together, these measures provide a comprehensive evaluation of both subjective and objective recovery following surgery.

Dexmedetomidine is associated with known, dose-dependent cardiovascular effects, including bradycardia and hypotension, and as such, safety monitoring is an integral component of the study design. Participants are monitored for hemodynamic events, sedation, and other adverse events throughout the infusion period and follow-up. A structured monitoring protocol and predefined criteria for intervention or discontinuation are used to mitigate risk and ensure participant safety.

The statistical approach follows an intention-to-treat framework. The study is powered to detect a clinically meaningful difference in quality of recovery based on established thresholds for the QoR-15 instrument. Secondary analyses explore differences in opioid exposure, pain trajectories, gastrointestinal recovery, and hospital length of stay, providing insight into potential mechanisms underlying any observed improvement in recovery.

By focusing on postoperative continuation of dexmedetomidine in a well-defined surgical population, this study aims to generate high-quality evidence addressing an unmet need in perioperative care. If effective, postoperative dexmedetomidine infusion could represent a scalable, low-cost strategy to enhance recovery, reduce opioid-related morbidity, and improve patient experience after bowel surgery. The findings may inform future perioperative analgesia protocols and contribute to the development of evidence-based guidelines for postoperative pain management in abdominal surgery.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pedro M Eman, MD; Phone Number: 7152 416-586-4800; Email: pedro.eman@sinaihealth.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
      • Sub-Investigator: Naveed Siddiqui, MD
      • Contact: Pedro M Eman, MD; Phone Number: 7152 416-586-4800; Email: pedro.eman@sinaihealth.ca
      • Contact: Jonathan Sy, MD; Phone Number: 6632 416-586-4800; Email: Jonathan.Sy@sinaihealth.ca
      • Principal Investigator: Yehoshua Gleicher, MD
      • Sub-Investigator: Erin Kennedy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Known allergy or hypersensitivity to dexmedetomidine.

2. Cardiac impairment defined as:

   1. Moderate or severe systolic dysfunction
   2. Moderate or severe valvulopathy (as per American Society of Echocardiography criteria)
   3. Significant bradycardia (baseline heart rate < 60) or
   4. Heart block without a pacemaker.
3. Active infection or sepsis at the time of surgery.
4. Use of medications with significant interactions with dexmedetomidine (e.g., MAO inhibitors).
5. Pregnant or breastfeeding individuals.
6. Current opioid use (> 30 mg daily oral morphine equivalent) or history of opioid use disorder.
7. Current clonidine use.
8. Patients undergoing thoracic epidurals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; 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; 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
Placebo Comparator: Placebo; 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; Arm Description: Postoperative matched placebo of 0.9% saline infusion for a total of 48 hours via a continuous ambulatory delivery device (CADD) pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery: QoR-15 scores at 24, 72 hours, and 7 days postoperatively.	The secondary outcome of the study is the Quality of Recovery (QoR-15) score at 24, 72 hours and, 7 days 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. These time points capture early, intermediate, and short-term recovery trajectories, allowing assessment of the sustained clinical impact of the study intervention beyond pain intensity alone.	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 Visual Analog Scale (VAS) at 24, 48, 72 hours, and 7 days, postoperatively.	Pain intensity will be assessed using the Visual Analog Scale (VAS) at 24, 48, 72 hours, and 7 days postoperatively to evaluate the effectiveness of the study intervention on acute and short-term postoperative pain control. The VAS is a validated, widely used patient-reported measure of pain intensity consisting of a 0-100 mm scale, where 0 represents "no pain" and 100 represents "worst imaginable pain." Higher scores indicate worse pain. These time points capture early and evolving postoperative pain trajectories and allow assessment of both immediate and sustained analgesic effects.	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
Hospital length of stay (LOS): Duration of postoperative hospitalization in days.		Up to 7 days post-operatively
Hemodynamic complications: incidences of systolic blood pressure <90 mmHg, incidences of heart rate <50 beats per minute throughout the intervention period, including 24 hours following completion of the intervention.		Up to 7 days post-operatively

Collaborators and Investigators

• Sponsor: Dr. Naveed Siddiqui
• Collaborators: Mount Sinai Hospital, Canada

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: quality of recovery; laparoscopy; laparoscopic surgery; postoperative pain; abdominal pain; bowel surgery; pain after surgery; recovery after surgery; bowel surgery pain; laparoscopy surgery pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Abdominal Pain; Inflammatory Bowel Diseases
• Other Study ID Numbers: 1308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No