Use of Dexmedetomidine to Improve Pain Control and Recovery After Laparocopic-Assisted Bowel Surgery in Adults
Phase 3 · Testing Dexmedetomidine infusion · 1 site · Dr. Naveed Siddiqui
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Dexmedetomidine infusion (a drug). Condition(s) listed: Bowel Diseases, Inflammatory, Bowel Surgery and Laparoscopic Abdominal Surgeries.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2026-07-01 (planned).
- Main results expected around 2027-07-01 (estimate from the record).
- 1 study site listed in Canada.
Main thing being measured
- Quality of recovery: QoR-15 scores at 48 hours postoperatively. (Up to 7 days post-operatively)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Bowel Diseases, Inflammatory; Bowel Surgery; Laparoscopic Abdominal Surgeries |
| Lead sponsor | Dr. Naveed Siddiqui |
| Collaborators | Mount Sinai Hospital, Canada |
| Enrollment | 70 (estimated) |
| Start date | 2026-07-01 |
| Primary completion (est.) | 2027-07-01 |
| First posted | 2026-02-25 |
| Last updated | 2026-06-24 |
| Official title | Postoperative Dexmedetomidine (PODEX) for Enhanced Recovery in Bowel Surgery: A Double-Blinded, Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT07434310 |
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 - 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
Full eligibility criteria (from the record)
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. 9. Patients with liver impairment with a Child-Pugh class of B (moderate) or C (severe).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital | Toronto, Ontario | Canada |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.