Analgesia Clinical Trial
Official title:
Comparing the Effect of Different Ratio of Propofol-Ketamine Mixture (Ketofol) (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Verified date | October 2019 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP
Status | Completed |
Enrollment | 58 |
Est. completion date | June 1, 2017 |
Est. primary completion date | May 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Having ERCP procedures using sedatives - ASA (American Society of Anesthesiologist) physical status Class I to III - Body mass index (BMI) of 18-30 kg/m2 - Willing to participate in the study Exclusion Criteria: - Patients with a history of allergic reaction to medications used in the study - Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction - Patients with unstable hemodynamic - Patients with psychiatric medications - Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo General Hospital | Jakarta Pusat | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Bahrami Gorji F, Amri P, Shokri J, Alereza H, Bijani A. Sedative and Analgesic Effects of Propofol-Fentanyl Versus Propofol-Ketamine During Endoscopic Retrograde Cholangiopancreatography: A Double-Blind Randomized Clinical Trial. Anesth Pain Med. 2016 Aug — View Citation
Coulter FL, Hannam JA, Anderson BJ. Ketofol dosing simulations for procedural sedation. Pediatr Emerg Care. 2014 Sep;30(9):621-30. doi: 10.1097/PEC.0000000000000222. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of Propofol Usage | Level of propofol needed during the procedure | 1 hour | |
Secondary | Recovery Time | Time needed to recover after the procedure | 15 minutes |
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