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

March 16, 2017 updated by: Yu-Hsi hsieh, Dalin Tzu Chi General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Chia-Yi, Taiwan, 622
        • Buddhist Dalin Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
1 ml normal saline will be given 5 minutes before EGD
Drug: placebo
Active Comparator: meperidine
25 mg intramuscular meperidine will be given 5 minutes before EGD
Drug: Meperidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discomfort score during esophageal intubation
Time Frame: 10 minutes
self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 (0 = none; 10 = unbearable) visual analog scale (VAS).
10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
patient discomfort score during the procedure
Time Frame: 10 minutes
10 minutes
patients satisfaction score
Time Frame: 10 minutes
10 minutes
patient tolerance score evaluated by the endoscopist
Time Frame: 10 minutes
10 minutes
endoscopist satisfaction score
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DalinTCGH-hsieh-2013-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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