The Application of Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for Pain Relief During Colonoscopy: a Prospective, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 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. Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) is a non-invasive modality that 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 Acu-TENS in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.
Design:
Prospective, randomized, placebo-controlled study.
Subjects:
One hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture/Acu-TENS will be recruited.
Interventions:
Patients will be randomized to receive either 45 minutes of Acu-TENS or placebo-TENS before colonoscopy. The acupoints relevant to the treatment of abdominal pain and distension, including Zusanli, Hegu, Neiguan, Tianshu, and Dachangshu will be used. For the placebo-TENS group, a non-conductive plastic film will be placed between the acupoint and the electrode so that no current will be transmitted. Acu-TENS and placebo-TENS 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 (Participant, 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
- 否
入选标准
- •Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy
- •Patients with American Society of Anesthesiologists (ASA) grading I-II
- •Informed consent available
排除标准
- •Patients with previous experience of acupuncture or Acu-TENS
- •Patients with previous history of colorectal surgery
- •Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria
- •Patients with chronic pain syndrome
- •Patients with psychiatric disorder
- •Patients with poor cognitive function
- •Patients with renal impairment
- •Patients with obstructive sleep apnea syndrome
- •Patients with cardiac arrhythmias
- •Patients with cardiac pacemaker
- •Patients who are pregnant
- •Patients who are allergic to the Acu-TENS electrodes or Propofol/Alfentanil
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
Simon S. M. Ng
Professor
Chinese University of Hong Kong