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

Dalin Tzu Chi General Hospital

Status: Completed

Conditions: Patients Undergoing Diagnostic EGD

Treatments: Drug: placebo; Drug: Meperidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01948921

DalinTCGH-hsieh-2013-3

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

1 ml normal saline will be given 5 minutes before EGD

Treatment:

Drug: placebo

meperidine

Active Comparator group

Description:

25 mg intramuscular meperidine will be given 5 minutes before EGD

Treatment:

Drug: Meperidine