Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:53 AM
Study NCT ID:
NCT07306702
Status:
COMPLETED
Last Update Posted:
2025-12-29
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients
Sponsor:
Shenyang Sixth People's Hospital
Organization:
Study Overview
Official Title:
Effect of Dexmedetomidine Combined With Oseltamivir Fumarate for Patient-controlled Intravenous Analgesia Following Lobectomy in Patients With Nicotine Dependence
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEX-PCIA
Brief 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.
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.
Detailed Description:
Adults scheduled for first-time thoracoscopic lobectomy at two centers are screened preoperatively; key exclusions include significant conduction abnormalities, severe organ dysfunction, inability to use PCIA, or recent exposure to α2-agonists/opioids that could confound results. After surgery, participants are randomized to one of three masked PCIA regimens. Study personnel, patients, and outcome assessors remain blinded. Standardized anesthetic and postoperative care pathways are followed. Pain (rest/movement visual analog scales), sedation (Ramsay), mood (self-rating anxiety/depression), comfort/function scales, and adverse events are recorded at prespecified time points through 48 hours; patient satisfaction is collected at 72 hours. Data are analyzed with appropriate parametric/non-parametric tests for continuous variables and χ²/Fisher's exact tests for categorical outcomes, with two-sided α=0.05.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JUH-CCP-RC-RETRO-01 | OTHER | Shenyang Sixth People's Hospital | View |