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临床试验/NCT03095898
NCT03095898Unknown不适用

Electroacupuncture Analgesia for Colonoscopy: A Prospective and Randomized Study

American University of Beirut Medical Center2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
180
试验地点
2
主要终点
Reduction in amount of analgesia

研究概览

简要总结

The objective of this study is to compare the effectiveness of acupuncture versus Sham acupuncture in reducing patient's discomfort and pain during colonoscopy with a standard sedation protocol. This will be objectively measured by the reduction in the amount of analgesia used as well as the time spent in the recovery room.

详细描述

Aim of the study

The objective of this study is to compare the effectiveness of acupuncture versus Sham acupuncture in reducing patient's discomfort and pain during colonoscopy with a standard sedation protocol. This will be objectively measured by the reduction in the amount of analgesia used as well as the time spent in the recovery room.

Background and significance

Colonoscopy is an invasive procedure, known to be uncomfortable for patients, necessitating the use of sedative drugs. The standard practice at the institution is to use conscious sedation with midazolam and fentanyl to achieve a satisfactory level of relaxation, cooperation, and amnesia during the procedure. Patients undergoing colonoscopy might experience abdominal cramps, pain and distension necessitating an increase in the sedation used in most of the times, in addition to aborting the procedure in rare cases. Previous studies have reported that the use of sedative and analgesic drugs frequently prolongs recovery room observation and brings rare but well-known adverse events like hypotension and respiratory compromise. To note that the former complications of conscious sedation are dependent on the doses of drugs used.

Acupuncture is a form of alternative medicine and is used worldwide for different indications, mainly for pain management. It relies on the stimulation of specific acupuncture points along the skin of the body using thin needles. It is based on the belief that a "life force" circulates within the body in lines called meridians. Each meridian corresponds to an internal organ. Only few publications exist with respect to the role of acupuncture for sedation during gastrointestinal procedures. These studies showed that that the stimulation of LI4, S36, SP6 and SP9 acupuncture points can decrease the demand for sedative drug, as well as gastrointestinal discomfort and pain by electrically stimulating bilateral active points.Sham acupuncture on the other hand uses analogous stimulation of inactive symmetrical points near the active points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Subjects undergoing colonoscopy as part of their clinical care
  • midazolam/fentanyl sedation
  • age above 18 years
  • ASA classification I-III,
  • Able to give written informed consent

排除标准

  • Age < 18 years
  • ASA classification VI and V
  • Allergic reaction to planned medication in the patients' medical history
  • Nickel allergy
  • Pacemaker/Implanted Cardioverter Device
  • Psychiatric and neurologic disorders including epilepsy
  • Use of anticoagulants and antiplatelet including aspirin
  • Previous colonic resection,
  • Patients refusing conscious sedation
  • Active GI bleeding
  • Patients who had any technical knowledge of acupuncture were also excluded to maintain blindness between acupuncture and sham acupuncture
  • Patients with arrhythmia
  • Patients with skin disorders in the vicinity of electrodes placement
  • Pregnant women

研究组 & 干预措施

True Acupuncture

Experimental

干预措施: Electroacupuncture (Device)

Sham Acupuncture

Sham Comparator

干预措施: Electroacupuncture (Device)

Control Group

No Intervention

结局指标

主要结局

Reduction in amount of analgesia

时间窗: 1 day per patient

Used dosage of midazolam, in combination with fentanyl

次要结局

  • Patients and gastroenterologist satisfaction(1 day per patient)
  • Time needed to complete the procedure(1 day per patient)
  • Time spent in the recovery room(1 day per patient)

研究者

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

Fady Daniel

Assistant Professor

American University of Beirut Medical Center

研究点 (2)

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