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

Not Applicable

Completed

• Conditions: Patients Undergoing Diagnostic EGD
• Interventions: Drug: placebo; Drug: Meperidine

• Registration Number: NCT01948921
• Lead Sponsor: Dalin Tzu Chi General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	1 ml normal saline will be given 5 minutes before EGD
meperidine	Meperidine	25 mg intramuscular meperidine will be given 5 minutes before EGD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
patient tolerance score evaluated by the endoscopist	10 minutes
patients satisfaction score	10 minutes
patient discomfort score during the procedure	10 minutes
endoscopist satisfaction score	10 minutes

Trial Locations

Locations (1)

Buddhist Dalin Tzu Chi General Hospital; 🇨🇳 Chia-Yi, Taiwan

Buddhist Dalin Tzu Chi General Hospital

🇨🇳Chia-Yi, Taiwan