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NCT Number: NCT07434310

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location contact

Erin Kennedy, MD

SUB_INVESTIGATOR

Jonathan Sy, MD

CONTACT

[email protected]

416-586-4800 ext. 6632

Naveed Siddiqui, MD

SUB_INVESTIGATOR

Pedro M Eman, MD

CONTACT

[email protected]

416-586-4800 ext. 7152

Yehoshua Gleicher, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: Up to 7 days post-operatively

    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.

Secondary outcomes

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

    Time frame: Up to 7 days post-operatively

    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.

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

    Time frame: Up to 7 days post-operatively

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

    Time frame: Up to 7 days post-operatively

    Pain intensity will be assessed using the Numeric Rating Scale (NRS) 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 Numeric Rating Scale (NRS) is a validated, widely used patient-reported measure of pain intensity consisting of an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 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.

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

    Time frame: Up to 7 days post-operatively

  5. 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.

    Time frame: Up to 7 days post-operatively

  6. Hospital length of stay (LOS): Duration of postoperative hospitalization in days.

    Time frame: Up to 7 days post-operatively

  7. 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.

    Time frame: Up to 7 days post-operatively

Study contacts

Contact information is provided by the study sponsor or research team.

Pedro M Eman, MD

CONTACT

[email protected]

416-586-4800 ext. 7152

Sponsors and collaborators

Lead sponsor

Dr. Naveed Siddiqui

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study title

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

Acronym: PODEX

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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