Phase 4
N=16
A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT00889720 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Aug 2011
Primary outcome: Primary: Percentage of Fully Compliant Participants — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Fully Compliant Participants |
— | — |
| PRIMARY Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition |
11; 1 | — |
| PRIMARY Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition |
11; 1 | — |
| PRIMARY Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition |
9; 2 | — |
| PRIMARY Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition |
9; 0 | — |
| PRIMARY Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection |
— | — |
| PRIMARY Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale |
10; 1; 1 | — |
| PRIMARY Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale |
8; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale |
8; 1; 2 | — |
| PRIMARY Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale |
8; 1 | — |
| PRIMARY Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3 |
7; 1 | — |
| PRIMARY Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 |
7; 1 | — |
| PRIMARY Wound Healing Grade by ASEPSIS Criteria at Week 12 |
6; 1 | — |
| PRIMARY Wound Healing Grade by ASEPSIS Criteria at Week 26 |
6; 0 | — |
| PRIMARY Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission. |
9 | — |
| SECONDARY Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System |
10; 1; 1; 7; 3; 1 | — |
| SECONDARY Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline. |
— | — |
| SECONDARY Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12) |
9 | — |
| SECONDARY Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26 |
7 | — |
| SECONDARY Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline. |
— | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline |
9; 8; 3; 1; 1; 0 | — |
| SECONDARY Number of Treatment Emergent Adverse Events by Severity |
13; 11; 4 | — |
Summary
It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.
Eligibility Criteria
Inclusion Criteria
- Smokers motivated to stop smoking scheduled for elective surgery
Exclusion Criteria
- Current or recent depression
- Current or recent suicidal ideation
- Uncontrolled or unstable clinically significant medical condition
Data sourced from ClinicalTrials.gov (NCT00889720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.