Clinical Trial

Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients

Study acronym: DEX-PCIA
Withdrawn Phase 4
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Why the trial stopped
needs major change in study protocol
Summary
This randomized, double-blind, controlled clinical trial evaluates whether adding dexmedetomidine to an oliceridine-based patient-controlled intravenous analgesia (PCIA) regimen can improve postoperative pain control and tolerability after video-assisted thoracoscopic lobectomy in adults with high nicotine dependence (Fagerström score ≥6). A total of 102 participants are allocated 1:1:1 into three groups: (1) oliceridine PCIA alone; (2) oliceridine PCIA plus low-dose dexmedetomidine (0.05 μg/kg/h); or (3) oliceridine PCIA plus standard-dose dexmedetomidine (0.1 μg/kg/h). PCIA solutions are prepared to 100 mL, delivered with a basal rate of 2 mL/h, a 0.5-mL bolus, and a 15-minute lockout; a small loading dose is given near the end of surgery. Tramadol is permitted as rescue analgesia per protocol. The primary objectives are to compare postoperative pain intensity at rest and with movement and overall patient satisfaction within 48-72 hours after surgery. Secondary objectives include sedation level, negative affect (anxiety/depression) scores, comfort and functional recovery scales, effective PCIA presses, rescue analgesic use, and safety outcomes (nausea/vomiting, shivering, bradycardia, hypotension, hypoxemia, and respiratory depression). Outcomes are assessed at approximately 4, 8, 12, 24, and 48 hours after surgery, with a satisfaction survey at 72 hours. The investigators hypothesize that oliceridine PCIA combined with dexmedetomidine-particularly at 0.1 μg/kg/h-will reduce movement-related pain, decrease rescue opioid needs and PCIA presses, improve mood and comfort scores, and maintain acceptable hemodynamic and respiratory safety compared with oliceridine alone.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2024-05-30 -> 2027-05-30 2026-04-14
minor Completion pushed: 2024-06-02 -> 2027-05-30 2026-04-14
Trial Details
NCT Number NCT07306702
Lead Sponsor Shenyang Sixth People's Hospital
Conditions Postoperative Pain Management
Start Date 2026-06-01
Primary Completion 2027-05-30 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-13