Reducing cardiovascular risk through smoking cessation before elective surgery. A randomized control trial of mailed nicotine replacement therapy (NRT) and behavioural support and relapse-prevention.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 516
研究概览
简要总结
Dr Ashley Webb, a staff anaesthetist at Peninsula Health and Monash University, and colleagues conducted a trial at Frankston Hospital involving adult smokers added to elective surgery waiting lists for operations at least 10 days in the future, between 1 April 2019 and 3 April 2020. In addition to normal care, participants in the intervention arm of the trial received a brochure on the risks of low frequency smoking, an offer of Quitline call-back registration, and an offer of mailed NRT (according to reported daily smoking: 1?9 cigarettes/day, 2 mg lozenges; 10?15/day, 7?14 mg patches [3 weeks] and 2 mg lozenges; > 15/day, 7?21 mg patches [5 weeks] and 2 mg lozenges). Of 748 eligible participants (control, 363; intervention, 385), 516 (69%) had undergone elective surgery when the trial was terminated early (for COVID-19-related reasons) (intervention group, 274; control group, 242) 122 of the 385 intervention participants (32%) had accepted the offer of cessation support. The proportions of intervention participants who quit at least 24 hours before surgery (18% v 9%) or at least 4 weeks before surgery (9% v 4%) were larger than for the control group. Three months after surgery, 27 of 58 intervention (47%) and 12 of 25 control participants (48%) who quit before surgery reported not smoking in the preceding 7 days. No major adverse events were reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Having elective surgery
- •Available for data collection on day of surgery
排除标准
- •1. Unable to understand study requirements
- •2. Age<18
- •3. Weight <45 kg (from preop HQ)
- •4.Pregnancy or breastfeeding
- •5. Contraindication to nicotine patch. eg allergy
- •6. Already on stop-smoking medication
- •7. No phone
- •8. Emergency surgery
- •9. Not available for data collection on day of surgery.
