Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery

NCT ID: NCT04572646

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2022-05-31

Brief Summary

Smoking is associated with a higher rate of surgical complications. For example, in orthopedics, the risk of complications is 31% in smokers against 5% in non-smokers. The management of this addiction is recommended and particularly interesting in scheduled surgery, because it allows smoking cessation well before the procedure. However, for patients who cannot consider this smoking cessation, the mere information of the risk cannot be sufficient and a real strategy must be constructed and evaluated.

Currently, studies results indicate that a patient reducing the number of smoked cigarettes will unconsciously modify their smoking behaviour to obtain the usual nicotine level, this effect is called self-titration. Conversely, nicotine replacement while continuing consumption could induce an improvement in smoking behaviour, therefore less intoxication which would be beneficial in terms of reduction of post-operative complications. This study seeks to assess the effectiveness of a systematic proposition of nicotine replacement therapy (NRT) in regular smokers. Tobacco addiction specialists have demonstrated that intoxication and dependence are well correlated with the exhaled carbon monoxide (CO) level, so this measurement will be used in addition to the patient's interview.

Conditions

Smoking Cessation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

NRT proposition and exhaled CO measurement

Group Type: OTHER

NRT proposition and exhaled CO measurement

Intervention Type: OTHER

Nicotine replacement therapy is proposed to every patient included in the study.

Whether the patient accepts the therapy or not, exhaled carbon monoxide is measured at the preoperative consultation (about 15 days before surgery) and the day of surgery by a nurse. These two measures are compared to assess efficacy of nicotine replacement therapy.

Interventions

NRT proposition and exhaled CO measurement

Nicotine replacement therapy is proposed to every patient included in the study.

Whether the patient accepts the therapy or not, exhaled carbon monoxide is measured at the preoperative consultation (about 15 days before surgery) and the day of surgery by a nurse. These two measures are compared to assess efficacy of nicotine replacement therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient who smokes at least one cigarette or cannabis joint per day, every day
• Patient received for nurse consultation at least 48 hours before surgery
• Patient planned to undergo surgery, with entry the day of surgery and 1 day of post-operative hospitalisation
• Patient in physical capacity and willing to undergo exhaled carbon monoxide measurement
• For patients with one of the following chronic diseases: diabetes, Chronic Obstructive Pulmonary Disease, glucose intolerance, hemolytic anemia, asthma and dilation of the bronchi, these diseases must be stable
• Signature of the specific study informed consent
• Patient affiliated or beneficiary of social security system

Exclusion Criteria

• Inability to submit to study follow-up for geographic, social or psychological reasons
• Patient already included in an interventional clinical research protocol
• Patients protected by French law from clinical research inclusion (pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation)
• Patient using nicotine substitutes before the nurse consultation
• Alcohol consumption six hours before the exhaled carbon monoxide measurement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier Mutualiste de Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe hospitalier Mutualiste de Grenoble

Grenoble, , France

Countries

France

Other Identifiers

2020/03-ECR-GHMG

Identifier Type: -

Identifier Source: org_study_id