Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients (DEX-PCIA)

April 8, 2026 updated by: Yu Shang, Shenyang Sixth People's Hospital

Effect of Dexmedetomidine Combined With Oseltamivir Fumarate for Patient-controlled Intravenous Analgesia Following Lobectomy in Patients With Nicotine Dependence

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110044
        • Shenyang Chest Hospital, Department of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status II-III
  • Male patients aged 65 years or younger
  • Undergoing lobectomy for the first time
  • High nicotine dependence, confirmed by the Fagerström Test for Nicotine Dependence (FTND) with an FTND score of 6 or higher
  • No history of substance abuse and no recent use of analgesic medications (e.g., opioids or non-steroidal anti-inflammatory drugs) prior to surgery
  • Able to understand the procedure for patient-controlled intravenous analgesia (PCIA) and able to complete the study assessment scales

Exclusion Criteria

  • History of mental illness or cognitive disorder; or currently receiving antidepressant treatment and unable to cooperate with examinations and assessments
  • Bradycardia (heart rate 50 beats/min or lower) or second- or third-degree atrioventricular block
  • Body mass index (BMI) greater than 30 kg/m²
  • Use of analgesics, sedatives, beta-blockers, or alpha-2 agonists prior to surgery
  • Required reoperation due to serious postoperative complications (e.g., bleeding)
  • Severe cardiovascular, cerebrovascular, hepatic, or renal disease, resulting in inability to remove the endotracheal tube after surgery or inability to use the analgesia pump correctly
  • Failure to abstain from smoking for at least 2 weeks prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Oliceridine PCIA Alone
Postoperative patient-controlled intravenous analgesia (PCIA) using oliceridine only. Reservoir 100 mL; basal 2 mL/h; bolus 0.5 mL; lockout 15 min; ~3 mL loading dose given near the end of surgery. Used for up to 48 h after lobectomy. Tramadol 50-100 mg IV permitted as rescue per protocol. No dexmedetomidine infusion.
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.
Experimental: Oliceridine + Low-Dose Dexmedetomidine
Same oliceridine PCIA parameters as Arm 1, plus a continuous IV infusion of dexmedetomidine at 0.05 μg/kg/h (0.05 mcg/kg/h) for up to 48 h postoperatively. Tramadol 50-100 mg IV permitted as rescue per protocol.
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.
Experimental: Oliceridine + Standard-Dose Dexmedetomidine
Same oliceridine PCIA parameters as Arm 1, plus a continuous IV infusion of dexmedetomidine at 0.10 μg/kg/h (0.1 mcg/kg/h) for up to 48 h postoperatively. Tramadol 50-100 mg IV permitted as rescue per protocol.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Movement-evoked pain intensity (VAS 0-10) within 48 hours after surgery
Time Frame: Within 48 hours after surgery (assessed at 4, 8, 12, 24, and 48 hours after surgery; primary endpoint is the mean VAS across all assessments during the first 48 hours after surgery).
Pain during standardized movement (deep breathing/cough or turning in bed) measured on a 10-cm visual analog scale (0=no pain, 10=worst imaginable pain). Trained nurses record scores at each time point. Higher scores indicate worse pain. The primary analysis compares groups on the mean of all movement VAS values collected from 0-48 h postoperatively.
Within 48 hours after surgery (assessed at 4, 8, 12, 24, and 48 hours after surgery; primary endpoint is the mean VAS across all assessments during the first 48 hours after surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYCHS6-LOB-PCIA-RCT-2023
  • JUH-CCP-RC-RETRO-01 (Other Identifier: Shenyang Sixth People's Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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