- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03196479
Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation
September 4, 2017 updated by: Rudyanto Sedono, Indonesia University
This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and 1:4 ratio for endoscopic retrograde procedure
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Central Jakarta, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ketamine:propofol ratio of 1:6
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
|
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
|
Active Comparator: ketamine:propofol ratio of 1:4
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery Time
Time Frame: Day 1
|
Recovery time after procedure has ended
|
Day 1
|
Propofol requirement
Time Frame: Day 1
|
Total dose of propofol used during ERCP
|
Day 1
|
Fentanyl requirement
Time Frame: Day 1
|
Total dose of fentanyl used during ERCP
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1097/pec.0b013e31815c9df6.
- 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. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1053/j.jvca.2003.09.008.
- 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. doi: 10.1053/jcan.2000.7933.
- 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.
Helpful Links
- Glomsaker TB. Endoscopic Retrograde Cholangiopancreatography (ERCP) in Norway. University of Bergen, 2013.
- 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.
- 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.
- Ketamine / propofol versus fentanyl / propofol for sedating obese patients undergoing endoscopic retrograde cholangiopancreatography ( ERCP )
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
June 30, 2017
Study Completion (Actual)
August 31, 2017
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (Actual)
June 22, 2017
Study Record Updates
Last Update Posted (Actual)
September 6, 2017
Last Update Submitted That Met QC Criteria
September 4, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Hypnotics and Sedatives
- Ketamine
- Propofol
Other Study ID Numbers
- IndonesiaUAnes017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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