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临床试验/ACTRN12619000032156
ACTRN12619000032156已完成4 期

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.

Dr Ashley Webb0 个研究点目标入组 516 人开始时间: 2019年1月11日最近更新:
适应症

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.

研究者

发起方
Dr Ashley Webb

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