Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery

NCT04572646 | Terminated

• 1 other identifier: 2020/03-ECR-GHMG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

postoperative complication; nicotine replacement therapy; exhaled carbon monoxide level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

NRT proposition and exhaled CO measurement

OTHER

Other: NRT proposition and exhaled CO measurement

Interventions

NRT proposition and exhaled CO measurement 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.

NRT proposition and exhaled CO measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to submit to study follow-up for geographic, social or psychological reasons
• Patient already included in an interventional clinical research protocol
• Patient using nicotine substitutes before the nurse consultation
• Alcohol consumption six hours before the exhaled carbon monoxide measurement

Sponsors & Collaborators

• Groupe Hospitalier Mutualiste de Grenoble: lead

Study Sites (1)

Groupe hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

MeSH Terms

Conditions

Smoking Cessation; Postoperative Complications

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 1, 2020
• Study Start: August 24, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2022-03

Locations

FR (1)