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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients Undergoing Diagnostic EGD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

1 ml normal saline will be given 5 minutes before EGD

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

meperidine

25 mg intramuscular meperidine will be given 5 minutes before EGD

Group Type ACTIVE_COMPARATOR

Meperidine

Intervention Type DRUG

Interventions

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placebo

Intervention Type DRUG

Meperidine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No