Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study

Conditions
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Esophagogastroduodenoscopy

Intervention / Treatment
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* Drug: Meperidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: meperidine<br>25 mg of meperidine is injected intramuscularly before EGD | Drug: Meperidine<br>* intramuscular, 25 mg, 5 to 10 minutes before EGD<br>|
| Placebo Comparator: placebo<br>placebo was given intramuscularly before EGD | Drug: normal saline<br>* 25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discomfort score during esophageal intubation | patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS) | 9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meperidine, esophagogastroduodenoscopy, unsedated, minimal sedation