Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy
This study has been completed.
Sponsor:
Dalin Tzu Chi General Hospital
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01547520
First received: February 28, 2012
Last updated: March 7, 2012
Last verified: March 2012
| Tracking Information | |||||
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| First Received Date ICMJE | February 28, 2012 | ||||
| Last Updated Date | March 7, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
discomfort score during esophageal intubation [ Time Frame: 9 months ] [ Designated as safety issue: No ] patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01547520 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy | ||||
| Official Title ICMJE | Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Esophagogastroduodenoscopy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 140 | ||||
| Completion Date | February 2012 | ||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Not Provided | ||||
| Ages | 20 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01547520 | ||||
| Other Study ID Numbers ICMJE | DalinTCGH-hsieh-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dalin Tzu Chi General Hospital | ||||
| Study Sponsor ICMJE | Dalin Tzu Chi General Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Dalin Tzu Chi General Hospital | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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