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Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01547520
Enrollment
140
Registered
2012-03-08
Start date
2011-06-30
Completion date
2012-02-29
Last updated
2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagogastroduodenoscopy

Keywords

meperidine, esophagogastroduodenoscopy, unsedated, minimal sedation

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.

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.

Interventions

DRUGMeperidine

intramuscular, 25 mg, 5 to 10 minutes before EGD

DRUGnormal saline

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

Sponsors

Dalin Tzu Chi General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Age
20 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
discomfort score during esophageal intubation9 monthspatient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)

Secondary

MeasureTime frameDescription
patient and endoscopist satisfaction score9 monthspatient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied
patient tolerance of the procedure9 monthspatolerace 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 ,9 monthsendoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026