MedTrace Logo

Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients

NCT07306702 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Postoperative Pain Management

Interventions

DRUG

Oliceridine

Patient-controlled intravenous analgesia (PCIA) after VATS lobectomy using oliceridine only. 100-mL reservoir; basal rate 2 mL/h; 0.5-mL bolus; 15-min lockout; \~3-mL loading near end of surgery; used for up to 48 h. Tramadol 50-100 mg IV permitted as rescue per protocol.

DRUG

Dexmedetomidine

Continuous IV infusion as an adjuvant to the oliceridine PCIA per group assignment for up to 48 h: 0.05 μg/kg/h in Arm 2 or 0.10 μg/kg/h in Arm 3. Infusion may be held for HR \<50 bpm or MAP \<65 mmHg per protocol.

Sponsors & Collaborators

  • Shenyang Sixth People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-05-30
Completion
2027-05-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306702 on ClinicalTrials.gov