Postoperative Pain ManagementPhase 4DEX-PCIANCT07306702
Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients
A Phase 4 study testing Oliceridine and Dexmedetomidine in people with Postoperative Pain Management, run by Shenyang Sixth People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Oliceridine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 May 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shenyang Chest Hospital, Department of Anesthesiology
Shenyang, Liaoning, 110044
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain Management
- Being tested
- Oliceridine, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine PCIA Alone | Active comparator | 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. Receives: Drug: Oliceridine |
| Oliceridine + Low-Dose Dexmedetomidine | Experimental | 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. Receives: Drug: Oliceridine; Drug: Dexmedetomidine |
| Oliceridine + Standard-Dose Dexmedetomidine | Experimental | 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. Receives: Drug: Oliceridine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement-evoked pain intensity (VAS 0-10) within 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jun 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Why it stopped: needs major change in study protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shang, Shenyang Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306702
- Sponsor's protocol ID
- SYCHS6-LOB-PCIA-RCT-2023
- Other IDs
- JUH-CCP-RC-RETRO-01
- Acronym
- DEX-PCIA
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Combined With Oseltamivir Fumarate for Patient-controlled Intravenous Analgesia Following Lobectomy in Patients With Nicotine Dependence
- ClinicalTrials.gov ID
- NCT07306702
- Acronym / sponsor ID
- DEX-PCIA / SYCHS6-LOB-PCIA-RCT-2023
- Conditions
- Postoperative Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: needs major change in study protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shenyang Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oliceridine PCIA Alone | Active comparator | Drug: OliceridinePostoperative 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. |
| Oliceridine + Low-Dose Dexmedetomidine | Experimental | Drug: Oliceridine, Drug: DexmedetomidineSame 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. |
| Oliceridine + Standard-Dose Dexmedetomidine | Experimental | Drug: Oliceridine, Drug: DexmedetomidineSame 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OliceridinePatient-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 | Oliceridine + Low-Dose Dexmedetomidine, Oliceridine + Standard-Dose Dexmedetomidine, Oliceridine PCIA Alone |
| DexmedetomidineContinuous 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. | Drug | Oliceridine + Low-Dose Dexmedetomidine, Oliceridine + Standard-Dose Dexmedetomidine |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine and Dexmedetomidine in people with Postoperative Pain Management, run by Shenyang Sixth People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.