Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery

Smoking Cessation Clinical Trial

— PATCHIR  

Official title:

Benefit of a Systematic Proposition of Nicotine Replacement Therapy Preoperatively for Patients Undergoing Planned Surgery and With Tobacco or Cannabis Addiction, Regardless of the Intention to Quit

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04572646
• Other study ID #: 2020/03-ECR-GHMG
• Status: Terminated
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2022
• Source: Groupe Hospitalier Mutualiste de Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Groupe hospitalier Mutualiste de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Mutualiste de Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients who refuse nicotine replacement therapy		At inclusion
Secondary	Effect of nicotine replacement therapy on the type of analgesics administrated		At inclusion, before surgery, and 2 days after surgery
Secondary	Effect of nicotine replacement therapy on the duration of analgesics administrated		At inclusion, before surgery, and 2 days after surgery
Secondary	Effect of nicotine replacement therapy on the dose of analgesics administrated		At inclusion, before surgery, and 2 days after surgery
Secondary	Number of smoking cessations		2 days after surgery
Secondary	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	Subgroup analysis of the primary endpoint according to predefined groups	At inclusion, and before surgery