Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation
Condition: Adult Patients Undergoing ERCP
Study type: Interventional

Summary: 
      This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and
      1:4 ratio for endoscopic retrograde procedure
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study.
      Intravenous (IV) cannula (20 G) , non-invasive blood pressure monitor, and pulse-oxymetry had
      been set on the subjects in endoscopic room. Vital signs were recorded. Subjects were then
      randomized into two groups (Ketamine:propofol ratio of 1:6 [K16] and ketamine:propofol ratio
      of 1:4 [K14]). K16 group's drug mixture was ketamine:propofol with ratio of 1:6, filled in 50
      cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml),
      and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg
      of propofol. K14 group's drug mixture was ketamine:propofol with ratio of 1:4, filled in 50
      cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml),
      and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg
      of propofol. Patient then was given initial bolus dose of 1 mg/kg body weight (BW) (based on
      propofol dose) and continued with maintenance dose of propofol (50 mcg/kg BW/minute, based on
      propofol dose). Maintenance dose could be increased by 10 mcg/kg BW/ minute if the subject
      still gave response to surgical stimulation or decreased by 10 mcg/kg BW/minute if
      hypotension occured. Onset of the drug, vital signs every 5 minutes, hypotension and
      desaturation events were recorded. If there were signs of pain such as tachycardia or
      hypertension, an additional dose of 25 mcg of fentanyl intravenous was given and recorded.
      After the endoscopic retrograde cholangiopancreatography (ERCP) finished, drugs were stopped
      and the total doses of propofol, drug administration speed, total dose of fentanyl used, and
      recovery time were recorded. Subjects were moved to the recovery room and observed for side
      effects event. Subjects were moved to the ward after aldrete score of 9-10.
    

Intervention name(s): ketamine and propofol mixture with 1:6 ratio; ketamine and propofol mixture with 1:4 ratio
Intervention type(s): Drug; Drug
Intervention description(s): K16: K16 group was received ketamine:propofol with ratio of 1:6, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml), and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg of propofol; K14 group was received ketamine:propofol with ratio of 1:4, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml), and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg of propofol
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care