Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
MALE
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

Led by Henan Provincial People's Hospital · Updated on 2026-01-22

80

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan

Zhengzhou, Henan, China, 450003

Actively Recruiting

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Research Team

W

Wei Li

CONTACT

J

Jiaqiang Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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