Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

Not Applicable

Completed

• Conditions: Esophagogastroduodenoscopy
• Interventions: Drug: Meperidine; Drug: normal saline

• Registration Number: NCT01547520
• Lead Sponsor: Dalin Tzu Chi General Hospital

Brief Summary

Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and analgesic effects, so its use may be helpful for patients receiving upper endoscopy.

Detailed Description

Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract examination and therapy, but it is uncomfortable for many patients. Meperidine has been widely used in colonoscopic examination for many years; however, its use in EGD has not been completely evaluated.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-28
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

• Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.

Exclusion Criteria

• A therapeutic upper endoscopic procedure, sedated endoscopy, contraindication to Buscopan (hyoscine N-butylbromide)
• Allergy to meperidine
• American Society of Anesthesiology (ASA) risk Class 3 or higher
• Renal failure
• Decompensated cirrhosis
• Aged less than 20 years or more than 65 years
• Pregnancy
• Refusal to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
meperidine	Meperidine	25 mg of meperidine is injected intramuscularly before EGD
placebo	normal saline	placebo was given intramuscularly before EGD

Primary Outcome Measures

Name	Time	Method
discomfort score during esophageal intubation	9 months	patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
patient and endoscopist satisfaction score	9 months	patient and endoscopist satisfaction with the procedure, score 0(not satisfied at all)-10 (very satisfied
patient tolerance of the procedure	9 months	patolerace of the EGD, evaluate by the endoscopist, score 0 (best tolerance)-10 (very poor tolerance, the procedure could not be completed)
endoscopist perception of patient tolerance ,	9 months	endoscopist evaluation of patient tolerance during EGD, score 0 (best tolerance)- 10 (worst tolerance, the procedure can not be completed)

Trial Locations

Locations (1)

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

Dalin Tzu Chi General Hospital

🇨🇳Chia-Yi, Taiwan