Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008628465772 Date of Approval: 18/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Ketofol versus Propofol Induction on Hemodynamic Profiles in Adult Elective Surgical Patients: - A Double Blind Randomized Controlled Trial.
Official scientific title Effectiveness of Ketofol versus Propofol Induction on Hemodynamic Profiles in Adult Elective Surgical Patients: - A Double Blind Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Most of the time propofol and ketamine has been used as induction agent in adult surgical patients but propofol may cause cardiorespiratory depression while ketamine increases heart rate and arterial blood pressure . Ketofol is admixture of both ketamine and propofol which is most commonly used for procedural sedation hence exploring its efficacy for induction will be paramount for clinical care of surgical patients. The aim of this proposal is to compare the hemodynamic conditions between ketofol and propofol for induction of general anesthesia for elective surgical patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/08/2020
Actual trial start date 20/08/2020
Anticipated date of last follow up 20/11/2020
Actual Last follow-up date 30/12/2020
Anticipated target sample size (number of participants) 125
Actual target sample size (number of participants) 62
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Propofol 2mg/kg 30 minutes The propofol dose will be weight-based as 2 mg/kg of propofol, a standard induction dose for an ASA I or II patient. This will be placed into a 20-mL syringe and mixed with normal saline to give a total volume of 20 ml. A 10-mL rescue syringe will be prepared in a similar way that if needed 1mg/kg of propofol will be given. 30 Active-Treatment of Control Group
Experimental Group Ketofol Ketofol( 1.5mg/kg of propofol is mixed with 0.75mg/kg of ketamine) 30 minutes after induction of anesthesia The ketofol dose will also weight based such that 0.75 mg/kg of ketamine and1.5 mg/kg of propofol mixed with normal saline to achieve a final volume of 20 ml. This dose is based on previous studies. A 10-mL rescue syringe will also prepared in a similar fashion that if needed 0.25mg/kg of ketamine and 0.5 mg/kg of propofol will be given. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- ASA I and II - Age 18-65 years - Obstetric, Neurosurgical and ENT surgery are excluded - Those on long time opioid use/ sedative preoperative adjunctive medications - Those who use psychotropic drugs - any known contraindications/allergy to ketamine or propofol - pre-operative anxious patients - patient in pain Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/12/2019 The Institutional Review Board of Dilla University College of Health sciences and Medicine
Ethics Committee Address
Street address City Postal code Country
dilla dilla 4400 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary endpoints were a change in hemodynamic parameters (MAP, SBP, and HR) from baseline immediately after induction, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, and 30 minutes within 30 minutes from induction
Secondary Outcome Secondary endpoints include postoperative pain, nausea, and vomiting incident was graded and recorded in the PACU. until discharge from PACU with Aldrete score of 10
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Referral and Teaching Hospital Dilla University Referral Hospital in Dilla Town Dilla Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University dilla Dilla 4400 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University dilla Dilla 4400 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyoum Hailu seyoumhailu44@gmail.com +2510921203310 dilla
City Postal code Country Position/Affiliation
Dilla 4400 Ethiopia Principal Investigator
Role Name Email Phone Street address
Public Enquiries Sileshi Hailu abebihailu911@gmail.com +2510913785100 dilla
City Postal code Country Position/Affiliation
Dilla 4400 Ethiopia first advisor
Role Name Email Phone Street address
Scientific Enquiries Hailemariam Getachew bekeozil16@gmail.com +2510912982067 dilla
City Postal code Country Position/Affiliation
Dilla 4400 Ethiopia Corresponding author
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results, Discussion and Summary Clinical Study Report,Statistical Analysis Plan Up to August ,2021 Ketofol, Propofol, Induction, Anesthesia,Hemodynammics
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information