Use of Dexmedetomidine to Improve Pain Control and Recovery After Laparocopic-Assisted Bowel Surgery in Adults
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDr. Naveed Siddiqui
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy or hypersensitivity to dexmedetomidine.
Moderate or severe systolic dysfunction
Moderate or severe valvulopathy (as per American Society of Echocardiography criteria)
Significant bradycardia (baseline heart rate < 60) or
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine infusion
DrugPostoperative 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 interventionArm Description: Postoperative matched placebo of 0.9% saline infusion for a total of 48 hours via a continuous ambulatory delivery device (CADD) pump
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: DexmedetomidineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 7 days post-operativelySecondary outcomes
1
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.
Time frame
Up to 7 days post-operatively2
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-operatively3
3. Pain management: Pain scores assessed by Numeric Rating Scale (NRS) at 24, 48, 72 hours, and 7 days, postoperatively.
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.
Time frame
Up to 7 days post-operatively4
Postoperative complications: Incidence of nausea, vomiting, ileus, pruritus, and sedation.
Time frame
Up to 7 days post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Naveed Siddiqui
Lead sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor institution
Mount Sinai Hospital, Canada
Collaborator
Source ClinicalTrials.gov
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