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
  Purpose

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 Intervention
Esophagogastroduodenoscopy
Drug: Meperidine
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Dalin Tzu Chi General Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 140
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547520

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01547520     History of Changes
Other Study ID Numbers: DalinTCGH-hsieh-02
Study First Received: February 28, 2012
Last Updated: March 7, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Dalin Tzu Chi General Hospital:
meperidine
esophagogastroduodenoscopy
unsedated
minimal sedation

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

ClinicalTrials.gov processed this record on April 17, 2014