Adult Patients Undergoing ERCP Clinical Trial
Official title:
Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation
Verified date | September 2017 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and 1:4 ratio for endoscopic retrograde procedure
Status | Completed |
Enrollment | 58 |
Est. completion date | August 31, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo Hospital | Central Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recovery Time | Recovery time after procedure has ended | Day 1 | |
Primary | Propofol requirement | Total dose of propofol used during ERCP | Day 1 | |
Primary | Fentanyl requirement | Total dose of fentanyl used during ERCP | Day 1 |