Postoperative Dexmedetomidine (PODEX) for Enhanced Recovery in Bowel Surgery: A Double-Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Quality of recovery: QoR-15 scores at 48 hours postoperatively.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Placebo
Postoperative matched placebo of 0.9% saline infusion for a total of 48 hours via a continuous ambulatory delivery device (CADD) pump
干预措施: Postoperative matched placebo of 0.9% saline infusion (Other)
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
干预措施: Dexmedetomidine infusion (Drug)
结局指标
主要结局
Quality of recovery: QoR-15 scores at 48 hours postoperatively.
时间窗: 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.
次要结局
- 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)
- 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 Visual Analog Scale (VAS) 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)
- 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)
研究者
Dr. Naveed Siddiqui
Associate Professor, Anesthesia, Faculty of Medicine, University of Toronto
Samuel Lunenfeld Research Institute, Mount Sinai Hospital