Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery

Not Applicable

Terminated

• Conditions: Smoking Cessation
• Interventions: Other: NRT proposition and exhaled CO measurement

• Registration Number: NCT04572646
• Lead Sponsor: Groupe Hospitalier Mutualiste de Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-24
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-10-01
• Status Verified: 2022-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NRT proposition and exhaled CO measurement	NRT proposition and exhaled CO measurement	-

Primary Outcome Measures

Name	Time	Method
Efficacy of a systematic proposition of nicotine replacement therapy, regardless of the intention to quit Change in exhaled carbon monoxide level between the two measurements, assessed by a carbon monoxide breath monitor	At inclusion, and before surgery

Secondary Outcome Measures

Name	Time	Method
Effect of nicotine replacement therapy on the dose of analgesics administrated	At inclusion, before surgery, and 2 days after surgery
Effect of nicotine replacement therapy on the type of analgesics administrated	At inclusion, before surgery, and 2 days after surgery
Effect of nicotine replacement therapy on the duration of analgesics administrated	At inclusion, before surgery, and 2 days after surgery
Efficacy of a systematic proposition of nicotine replacement therapy, depending on the intention to quit Change in exhaled carbon monoxide level between the two measurements, assessed by a carbon monoxide breath monitor	At inclusion, and before surgery	Subgroup analysis of the primary endpoint according to predefined groups
Number of smoking cessations	2 days after surgery
Number of patients who refuse nicotine replacement therapy	At inclusion

Trial Locations

Locations (1)

Groupe hospitalier Mutualiste de Grenoble; 🇫🇷 Grenoble, France