Clinical Trials Directory

Trials / Terminated

TerminatedNCT04572646

Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Groupe Hospitalier Mutualiste de Grenoble · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERNRT proposition and exhaled CO measurementNicotine 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.

Timeline

Start date
2020-08-24
Primary completion
2022-05-31
Completion
2022-05-31
First posted
2020-10-01
Last updated
2023-02-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04572646. Inclusion in this directory is not an endorsement.