Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196479
• Other study ID #: IndonesiaUAnes017
• Status: Completed
• Phase: N/A
• First received: June 20, 2017
• Last updated: September 4, 2017
• Start date: March 1, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adult Patients Undergoing ERCP

Intervention

Drug:
• ketamine and propofol mixture with 1:6 ratio
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
• ketamine and propofol mixture with 1:4 ratio
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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Central Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

Andolfatto G, Willman E. A prospective case series of pediatric procedural sedation and analgesia in the emergency department using single-syringe ketamine-propofol combination (ketofol). Acad Emerg Med. 2010 Feb;17(2):194-201. doi: 10.1111/j.1553-2712.2009.00646.x. — View Citation

ASGE Standards of Practice Committee, Early DS, Ben-Menachem T, Decker GA, Evans JA, Fanelli RD, Fisher DA, Fukami N, Hwang JH, Jain R, Jue TL, Khan KM, Malpas PM, Maple JT, Sharaf RS, Dominitz JA, Cash BD. Appropriate use of GI endoscopy. Gastrointest Endosc. 2012 Jun;75(6):1127-31. doi: 10.1016/j.gie.2012.01.011. — View Citation

Botero CA, Smith CE, Holbrook C, Chavez AM, Snow NJ, Hagen JF, Pinchak AC. Total intravenous anesthesia with a propofol-ketamine combination during coronary artery surgery. J Cardiothorac Vasc Anesth. 2000 Aug;14(4):409-15. — View Citation

Coulter FL, Hannam JA, Anderson BJ. Ketofol simulations for dosing in pediatric anesthesia. Paediatr Anaesth. 2014 Aug;24(8):806-12. doi: 10.1111/pan.12386. Epub 2014 Mar 26. — View Citation

Goudra BG, Singh PM. Propofol alternatives in gastrointestinal endoscopy anesthesia. Saudi J Anaesth. 2014 Oct;8(4):540-5. doi: 10.4103/1658-354X.140893. Review. — View Citation

Kogan A, Efrat R, Katz J, Vidne BA. Propofol-ketamine mixture for anesthesia in pediatric patients undergoing cardiac catheterization. J Cardiothorac Vasc Anesth. 2003 Dec;17(6):691-3. — View Citation

Nwokediuko SC, Obienu O. Sedation practices for routine diagnostic upper gastrointestinal endoscopy in Nigeria. World J Gastrointest Endosc. 2012 Jun 16;4(6):260-5. doi: 10.4253/wjge.v4.i6.260. — View Citation

Sharieff GQ, Trocinski DR, Kanegaye JT, Fisher B, Harley JR. Ketamine-propofol combination sedation for fracture reduction in the pediatric emergency department. Pediatr Emerg Care. 2007 Dec;23(12):881-4. — View Citation

Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463. Review. — View Citation

Outcome

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

External Links

•   Donnelly RF, Willman E, Andolfatto G. Stability of Ketamine - Propofol Mixtures for Procedural Sedation and Analgesia in the Emergency Department. Can J Hosp Pharm 2008; 61: 426-430.
•   Glomsaker TB. Endoscopic Retrograde Cholangiopancreatography (ERCP) in Norway. University of Bergen, 2013.
•   Ketamine / propofol versus fentanyl / propofol for sedating obese patients undergoing endoscopic retrograde cholangiopancreatography ( ERCP )
•   Wang Y. A randomized double-blind controlled study of the efficacy of ketofol with propofol-fentanyl and propofol alone in termination of pregnancy. African J Pharm Pharmacol 2012; 6: 2510-2514.