Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
=================
Brief Summary
-----------------
Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Detailed Description
-----------------
Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

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)

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Propofol and Ketamine Mixture (Ketofol)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K61<br>Patients in K61 group received propofol and ketamine in a ratio of 6:1. The 6:1 ketofol mixture was made by mixing 30 mL of 1% propofol (10 mg/mL) and 1 mL of ketamine (50 mg/ml), then 19 mL of 0.9% NaCl was added until the volume of the mixture was 50 mL. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun). | Drug: Propofol and Ketamine Mixture (Ketofol)<br>* Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1<br>|
| Experimental: K41<br>Patients in K41 group received propofol and ketamine in a ratio of 4:1. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun). | Drug: Propofol and Ketamine Mixture (Ketofol)<br>* Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Propofol Usage | Level of propofol needed during the procedure | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Time | Time needed to recover after the procedure | 15 minutes |