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Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study

RecruitingNAAges 18 Years - 75 YearsMaleHenan Provincial People's Hospital
NCT07250230 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 irrit

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📋 Eligibility rules (as published)
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
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What it tests

  • Nicotine patch
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Where

1 site
Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan
Zhengzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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