Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547520
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

Brief Summary:
Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and analgesic effects, so its use may be helpful for patients receiving upper endoscopy.

Condition or disease Intervention/treatment Phase
Esophagogastroduodenoscopy Drug: Meperidine Drug: normal saline Not Applicable

Detailed Description:
Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract examination and therapy, but it is uncomfortable for many patients. Meperidine has been widely used in colonoscopic examination for many years; however, its use in EGD has not been completely evaluated.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study
Study Start Date : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: meperidine
25 mg of meperidine is injected intramuscularly before EGD
Drug: Meperidine
intramuscular, 25 mg, 5 to 10 minutes before EGD
Placebo Comparator: placebo
placebo was given intramuscularly before EGD
Drug: normal saline
25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD

Primary Outcome Measures :
  1. discomfort score during esophageal intubation [ Time Frame: 9 months ]
    patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)

Secondary Outcome Measures :
  1. patient and endoscopist satisfaction score [ Time Frame: 9 months ]
    patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied

  2. patient tolerance of the procedure [ Time Frame: 9 months ]
    patolerace of the EGD, evaluate by the endoscopist, score 0 (best tolerance)-10 (very poor tolerance, the procedure could not be completed)

  3. endoscopist perception of patient tolerance , [ Time Frame: 9 months ]
    endoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.

Exclusion Criteria:

  • A therapeutic upper endoscopic procedure, sedated endoscopy, contraindication to Buscopan (hyoscine N-butylbromide)
  • Allergy to meperidine
  • American Society of Anesthesiology (ASA) risk Class 3 or higher
  • Renal failure
  • Decompensated cirrhosis
  • Aged less than 20 years or more than 65 years
  • Pregnancy
  • Refusal to provide written informed consent.

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 identifier (NCT number): NCT01547520

Dalin Tzu Chi General Hospital
Chia-Yi, Taiwan, 622
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Principal Investigator: Yu-Hsi Hsieh, Dr. Dalin Tzu Chi General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dalin Tzu Chi General Hospital Identifier: NCT01547520     History of Changes
Other Study ID Numbers: DalinTCGH-hsieh-02
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Dalin Tzu Chi General Hospital:
minimal sedation

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia