Clinical trial NCT04572646: Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Keywords: postoperative complication
nicotine replacement therapy
exhaled carbon monoxide level
Lead sponsor: Groupe Hospitalier Mutualiste de Grenoble
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: At inclusion, and before surgery
Secondary outcomes:
measure: Number of patients who refuse nicotine replacement therapy
timeFrame: At inclusion
measure: Effect of nicotine replacement therapy on the type of analgesics administrated
timeFrame: At inclusion, before surgery, and 2 days after surgery
measure: Effect of nicotine replacement therapy on the duration of analgesics administrated
timeFrame: At inclusion, before surgery, and 2 days after surgery
measure: Effect of nicotine replacement therapy on the dose of analgesics administrated
timeFrame: At inclusion, before surgery, and 2 days after surgery
measure: Number of smoking cessations
timeFrame: 2 days after surgery
measure: 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
timeFrame: At inclusion, and before surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Groupe hospitalier Mutualiste de Grenoble
Study officials:
References: