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

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ClinicalTrials.gov Identifier: NCT01948921
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Yu-Hsi hsieh, 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.

Condition or disease Intervention/treatment Phase
Patients Undergoing Diagnostic EGD Drug: placebo Drug: Meperidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.
Study Start Date : September 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo
1 ml normal saline will be given 5 minutes before EGD
Drug: placebo
Active Comparator: meperidine
25 mg intramuscular meperidine will be given 5 minutes before EGD
Drug: Meperidine



Primary Outcome Measures :
  1. discomfort score during esophageal intubation [ Time Frame: 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 :
  1. patient discomfort score during the procedure [ Time Frame: 10 minutes ]
  2. patients satisfaction score [ Time Frame: 10 minutes ]
  3. patient tolerance score evaluated by the endoscopist [ Time Frame: 10 minutes ]
  4. endoscopist satisfaction score [ Time Frame: 10 minutes ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948921


Locations
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Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chia-Yi, Taiwan, 622
Sponsors and Collaborators
Dalin Tzu Chi General Hospital

Publications:
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Responsible Party: Yu-Hsi hsieh, Chief of Gastroenterology Endoscopy Suite, Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01948921     History of Changes
Other Study ID Numbers: DalinTCGH-hsieh-2013-3
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017
Keywords provided by Yu-Hsi hsieh, Dalin Tzu Chi General Hospital:
EGD
tolerance
discomfort
Additional relevant MeSH terms:
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Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia