NCT07250230 Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study
| NCT ID | NCT07250230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henan Provincial People's Hospital |
| Condition | Nicotine Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-11-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-11-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Globally, approximately 230 million adults undergo surgical procedures each year, with around 30% of patients maintaining smoking habits prior to surgery. Extensive clinical research has confirmed that tobacco exposure is a significant independent risk factor for perioperative complications. Epidemiological data indicate that long-term smokers experience a significantly higher all-cause mortality rate during hospitalization, approximately 20% greater than non-smokers, while the incidence of postoperative complications is 40% higher. Consequently, international guidelines universally recommend the establishment of standardized preoperative smoking cessation programs for surgical patients. Nicotine withdrawal, a typical clinical manifestation during smoking cessation, involves symptoms across multiple systems: neuropsychiatric symptoms such as mood depression, sleep disturbances, and irritability; autonomic dysfunction leading to postural dizziness and bradycardia; and metabolic dysregulation resulting in increased appetite and weight gain. Notably, these withdrawal symptoms exhibit a significant time-dependent pattern, typically peaking 24-72 hours after cessation. Multicenter studies have demonstrated that tobacco-dependent patients experience an average increase of IV Abstract 35-45% in opioid consumption within 24 hours postoperatively, with the duration of analgesic requirements extended by approximately 25%. However, some patients suffer from severe adverse reactions to opioids (e.g., nausea, vomiting, confusion), making the use of adjuvant medications for multimodal analgesia and optimized pain management particularly crucial. By the late 20th century, the analgesic properties of nicotine, a primary component of tobacco, were systematically studied and applied in clinical practice.
Eligibility Criteria
Inclusion Criteria: 1. Male, aged 18-75 years, with a body mass index (BMI) of 18-28 kg/m2 Between; 2. Thoracoscopic lobectomy/segmental/wedge resection under general anesthesia; 3. American Society of Anesthesiologists (ASA) classifications I-III Level; 4. Regular smoking for more than 2 years, smoking more than 10 cigarettes per day in the past 6 months, and not successfully quitting smoking within 1 month (after admission, the doctor and nurse informed the smoking cessation plan to intervene before starting to stop smoking or 1 ≤ cigarette count ≤ 10 cigarettes/day in the past month), FTND score ≥ 2; 5. No severe respiratory diseases, no serious cardiovascular and cerebrovascular diseases (hypertension is treated with SBP ≤ 160mmHg, DBP ≤ 90mmHg after systemic treatment); 6. Obtain informed consent. Exclusion Criteria: 1. Those who have a history of alcoholism, long-term use of sedatives or analgesics; 2. Patients with psychiatric and nervous system diseases (such as Parkinson's, depression, schizophrenia) and severe audio-visual dysfunction before surgery; 3. Preoperative systolic blood pressure \> 180mmHg or diastolic blood pressure \> 110mmHg; 4. Patients who were converted to thoracotomy during thoracoscopic surgery 5. Patients who are transferred to the intensive care unit after surgery; 6. Patients who refuse to use analgesic pump treatment/do not configure the analgesic pump according to regulations; 7. Patients who have self-removed patches/short hospital stay resulting in a postoperative observation time of \< 48 hours
Contact & Investigator
Jiaqiang Zhang, PHD
STUDY CHAIR
Henan Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT07250230 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 75 Years, studying Nicotine Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07250230 currently recruiting?
Yes, NCT07250230 is actively recruiting participants. Contact the research team at 1131691709@qq.com for enrollment information.
Where is the NCT07250230 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07250230 clinical trial?
NCT07250230 is sponsored by Henan Provincial People's Hospital. The principal investigator is Jiaqiang Zhang, PHD at Henan Provincial People's Hospital. The trial plans to enroll 80 participants.