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.: PACTR202407472796548 Date of Registration: 31/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fenofol and ketofol conscious sedation for surgical procedures: a randomized double-blind controlled study
Official scientific title Fenofol and ketofol conscious sedation for surgical procedures: a randomized double-blind controlled study
Brief summary describing the background and objectives of the trial Several surgical procedures like are of short duration and just require analgesia and moderate sedation. Ketofol, a combination of the drugs ketamine and propofol has good analgesic and sedative properties in addition to a fast onset of action thus making it ideal for short procedures. Fenofol is a combination of drugs Fentanyl and Propofol. in our study we. compare the sedative effecacy of fenofol versus ketofol in conscious sedation
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 14/07/2024
Actual trial start date 14/07/2024
Anticipated date of last follow up 12/09/2024
Actual Last follow-up date 17/10/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group c 1 mg/kg propofol from the start of procedures to the exit from PACU 1 mg/kg propofol 30 Active-Treatment of Control Group
Experimental Group group K 1 mg/kg propofol and 0.5 mg/kg ketamine from the start of procedures to the exit from PACU 1 mg/kg propofol and 0.5 mg/kg ketamine 30
Experimental Group group F 1 mg/kg propofol and 1 mic/kg fentanyl from the start of procedures till the exit from the PACU 1 mg/kg propofol and 1 mic/kg fentanyl 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
20 and 60 years physical status I and II scheduled for surgical procedures under conscious sedation with uncontrolled systemic disease, allergy to local anaesthetic or study drugs, chronic analgesic or sedative usage and alcohol or substance abuse Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 Year(s) Male
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
No 01/08/2024 menoufia university faculty of medicine research ethical committee
Ethics Committee Address
Street address City Postal code Country
25- yassen abdel ghafar shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the additional amount of propofol needed during procedures
Secondary Outcome Sedation onset, requirements for sevoflurane, Vital signs, the sedation time, The recovery time, The patient’s satisfaction ,and Adverse events during procedures and PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofia university hospital 25- yassen abdel ghafar shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha afify 25- yassen abdel ghafar shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine . menofia university 25- yassen abdel ghafar shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghafar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia intensive care and pain management
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghafar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia intensive care and pain management
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghafar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor of anesthesia and intensive care and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Immediately following publication, No end date Study Protocol unpredictable unavailable
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