Skip to main content
Clinical Trials/NCT03095898
NCT03095898UnknownNot Applicable

Electroacupuncture Analgesia for Colonoscopy: A Prospective and Randomized Study

American University of Beirut Medical Center1 site in 1 country180 target enrollmentStarted: January 9, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
180
Locations
1
Primary Endpoint
Reduction in amount of analgesia

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Sham Acupuncture

Sham Comparator

Intervention: Electroacupuncture (Device)

True Acupuncture

Experimental

Intervention: Electroacupuncture (Device)

Control Group

No Intervention

Outcomes

Primary Outcomes

Reduction in amount of analgesia

Time Frame: 1 day per patient

Used dosage of midazolam, in combination with fentanyl

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fady Daniel

Assistant Professor

American University of Beirut Medical Center

Study Sites (1)

Loading locations...

Similar Trials