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Meperidine for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01948921
Enrollment
110
Registered
2013-09-24
Start date
2013-09-30
Completion date
2017-03-31
Last updated
2017-03-20

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

Conditions

Patients Undergoing Diagnostic EGD

Keywords

EGD, tolerance, discomfort

Brief summary

Our pilot results showed that meperidine reduce patient discomfort during EGD (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative agents. So the investigators target the use of meperidine on patients expected to have poor tolerance in this study, which includ young females with high anxiety level and patients with prior poor tolerance. The investigators test the hypothesis that meperidine improves tolerance and alleviates discomfort for patients expected to have poor tolerance during diagnostic EGD.

Interventions

DRUGplacebo
DRUGMeperidine

Sponsors

Dalin Tzu Chi General Hospital
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* female youger than 65 years with high anxiety level * patients with previous poor tolerance of EGD

Exclusion criteria

* a therapeutic EGD * sedation with other agents * contraindication to Buscopan (hyoscine N-butylbromide) or meperidine * American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure * age less than 20 years or more than 80 years * pregnancy * refusal to provide written informed consent. All participants signed written informed consents

Design outcomes

Primary

MeasureTime frameDescription
discomfort score during esophageal intubation10 minutesself-reported discomfort score during esophageal intubation, assessed with a 0 to 10 (0 = none; 10 = unbearable) visual analog scale (VAS).

Secondary

MeasureTime frame
patient discomfort score during the procedure10 minutes
patients satisfaction score10 minutes
patient tolerance score evaluated by the endoscopist10 minutes
endoscopist satisfaction score10 minutes

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026