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Electroacupuncture Analgesia for Colonoscopy

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ClinicalTrials.gov Identifier: NCT01368393
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Procedure: Electroacupuncture Procedure: Sham acupuncture Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-controlled Study
Study Start Date : October 2011
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Electroacupuncture Procedure: Electroacupuncture
Patients randomized to the experimental group will receive electroacupuncture at acupoints relevant to the treatment of abdominal pain and anxiety, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), and Neiguan (pericardium meridian PC-6). Electric stimulation will be employed to the needles
Active Comparator: Sham acupuncture Procedure: Sham acupuncture
Sterile blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. "Pseudostimulation" will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.


Outcome Measures

Primary Outcome Measures :
  1. Dose of patient-controlled sedation/analgesia consumed [ Time Frame: During the procedure (up to 1 day) ]

Secondary Outcome Measures :
  1. Pain score [ Time Frame: During the procedure (up to 1 day) ]
    Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful

  2. Patients' satisfaction score [ Time Frame: During the procedure (up to 1 day) ]
    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  3. Patients' willingness to repeat the procedure [ Time Frame: Up to 1 day ]
  4. Endoscopists' satisfaction score [ Time Frame: During the procedure (up to 1 day) ]
    Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied

  5. Cecal intubation rate [ Time Frame: During the procedure (up to 1 day) ]
    Complete colonoscopy is defined as identification of ileocecal valve

  6. Cecal intubation time [ Time Frame: During the procedure (up to 1 day) ]
    The time from introduction of the colonoscope to the cecum

  7. Total procedure time [ Time Frame: During the procedure (up to 1 day) ]
  8. Episodes of hypotension [ Time Frame: During the procedure (up to 1 day) ]
    Defined as systolic blood pressure <90 mmHg

  9. Episodes of desaturation [ Time Frame: During the procedure (up to 1 day) ]
    Defined as SaO2 <90%


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • Patients with previous experience of acupuncture
  • 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 acupuncture needles or Propofol/Alfentanil
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368393


Locations
China
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Simon SM Ng, MD Chinese University of Hong Kong
More Information

Responsible Party: Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01368393     History of Changes
Other Study ID Numbers: CRE-2010.404
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012