Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01547520
First received: February 28, 2012
Last updated: March 7, 2012
Last verified: March 2012

February 28, 2012
March 7, 2012
June 2011
February 2012   (final data collection date for primary outcome measure)
discomfort score during esophageal intubation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)
Same as current
Complete list of historical versions of study NCT01547520 on ClinicalTrials.gov Archive Site
  • patient and endoscopist satisfaction score [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied
  • patient tolerance of the procedure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    patolerace of the EGD, evaluate by the endoscopist, score 0 (best tolerance)-10 (very poor tolerance, the procedure could not be completed)
  • endoscopist perception of patient tolerance , [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    endoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)
Same as current
Not Provided
Not Provided
 
Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy
Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Esophagogastroduodenoscopy
  • Drug: Meperidine
    intramuscular, 25 mg, 5 to 10 minutes before EGD
  • Drug: normal saline
    25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD
  • Experimental: meperidine
    25 mg of meperidine is injected intramuscularly before EGD
    Intervention: Drug: Meperidine
  • Placebo Comparator: placebo
    placebo was given intramuscularly before EGD
    Intervention: Drug: normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Not Provided
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01547520
DalinTCGH-hsieh-02
No
Dalin Tzu Chi General Hospital
Dalin Tzu Chi General Hospital
Not Provided
Principal Investigator: Yu-Hsi Hsieh, Dr. Dalin Tzu Chi General Hospital
Dalin Tzu Chi General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP