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OpenTrials
Completed

NCT Number: NCT01948921

Meperidine 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.

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Key information

Conditions

Patients Undergoing Diagnostic EGD

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan, 622

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Placebo

Drug

Meperidine

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. patient discomfort score during the procedure

    Time frame: 10 minutes

  2. patients satisfaction score

    Time frame: 10 minutes

  3. patient tolerance score evaluated by the endoscopist

    Time frame: 10 minutes

  4. endoscopist satisfaction score

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2013
Registry last updated
Mar 20, 2017

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.