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Completed

NCT Number: NCT01547520

Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

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.

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Key information

Conditions

Esophagogastroduodenoscopy

Age range

20 year–65 year

Study type

Interventional

Phase

Not applicable

Primary location

Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meperidine

Drug

intramuscular, 25 mg, 5 to 10 minutes before EGD

normal saline

Drug

25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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