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临床试验/NCT01368393
NCT01368393已完成3 期

Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-controlled Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
128
试验地点
1
主要终点
Dose of patient-controlled sedation/analgesia consumed

研究概览

简要总结

Background:

Colonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA) has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.

Objective:

To investigate the efficacy of EA in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.

Design:

Prospective, randomized, double-blind, sham-controlled study.

Subjects:

One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited.

Interventions:

Patients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA) before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to stabilize the needles and to blind the patients and endoscopists to the treatment allocation. EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.

Outcome measures:

Primary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Dose of patient-controlled sedation/analgesia consumed

时间窗: During the procedure (up to 1 day)

次要结局

  • Pain score(During the procedure (up to 1 day))
  • Patients' satisfaction score(During the procedure (up to 1 day))
  • Patients' willingness to repeat the procedure(Up to 1 day)
  • Endoscopists' satisfaction score(During the procedure (up to 1 day))
  • Cecal intubation rate(During the procedure (up to 1 day))
  • Cecal intubation time(During the procedure (up to 1 day))
  • Total procedure time(During the procedure (up to 1 day))
  • Episodes of hypotension(During the procedure (up to 1 day))
  • Episodes of desaturation(During the procedure (up to 1 day))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon S. M. Ng

Professor

Chinese University of Hong Kong

研究点 (1)

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