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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03196479 |
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Date of registration:
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20/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation
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Scientific title:
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Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03196479 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who were going to undergo ERCP unders sedation. Patient with American Society
of Anesthesiologists (ASA) physical status of I-III, and body mass index of 18-30
kg/m2.
Exclusion Criteria:
- Subjects with history of allergy with drugs used in this trial, subjects with
cardiovascular disease, hypertension, respiratory disorder, pregnancy, unstable
hemodynamic, psychiatric drugs consumption, possibility of difficult airway, and
kidney disorder
Drop out Criteria:
- drug allergy during procedure, hypotension (>20%) not resolved using ephedrine,
desaturation (oxygen saturation <90%) not resolved using positive pressure
ventilation, and endoscopic complication occur
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adult Patients Undergoing ERCP
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Intervention(s)
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Drug: ketamine and propofol mixture with 1:4 ratio
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Drug: ketamine and propofol mixture with 1:6 ratio
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Primary Outcome(s)
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Recovery Time
[Time Frame: Day 1]
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Fentanyl requirement
[Time Frame: Day 1]
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Propofol requirement
[Time Frame: Day 1]
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Secondary ID(s)
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IndonesiaUAnes017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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