Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery (PATCHIR)

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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: NRT proposition and exhaled CO measurement

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38028
    • Groupe hospitalier mutualiste de Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NRT proposition and exhaled CO measurement	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Number of patients who refuse nicotine replacement therapy		At inclusion
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
Effect of nicotine replacement therapy on the dose of analgesics administrated		At inclusion, before surgery, and 2 days after surgery
Number of smoking cessations		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	Subgroup analysis of the primary endpoint according to predefined groups	At inclusion, and before surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Mutualiste de Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: postoperative complication; nicotine replacement therapy; exhaled carbon monoxide level
• Other Study ID Numbers: 2020/03-ECR-GHMG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No