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.: PACTR201907799024111 Date of Approval: 05/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Propofol versus Ketofol in Endoscopic retrograde cholangiopancreatography ERCP BIS guided sedation
Official scientific title Propofol versus Ketofol in Endoscopic retrograde cholangiopancreatography ERCP BIS guided sedation
Brief summary describing the background and objectives of the trial Several factors are important in determining whether a sedative–analgesic combination is clinically acceptable. The ideal sedative–analgesic combination would provide a stable hemodynamic state, no respiratory depression, a rapid onset and recovery to baseline, and a low incidence of postoperative nausea and vomiting. Also will maintain a patient’s hemodynamic status to as close to the presedation state as possible. There is a significant interest in ketofol as an agent for procedural sedation and analgesia. A combination of ketamine and propofol can be used that can be mixed in the same syringe or administered independently in two separate syringes. Ketofol can be administered as boluses or as a continuous infusion for longer procedures. Endoscopic Retrograde Cholangiopancreatography (ERCP) when sedated with propofol, related adverse events (SRAES) includes; hypotension, arrhythmia, oxygen desaturation, unplanned intubation and procedure termination. Aim: Primary aim of the study was to compare propofol and ketofol as a sedative agent regards induction time and recovery time in adult patients undergoing ERCP. Secondary aim was to investigate the safety and efficacy of both drugs as regards haemodynamic, respiratory compromise, pain, nausea, vomiting, any psychomimetic effect (Agitation, Irritability…) post procedure patient and endoscopiest satisfaction as well as the total dose of drug consumption.
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 23/02/2018
Actual trial start date 23/02/2018
Anticipated date of last follow up 17/07/2019
Actual Last follow-up date 17/07/2019
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Active, not recruiting
Publication URL 23/2/2018
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group propofol group The 1st (P group) received an intravenous propofol loading dose of 1.5mg/kg over 5 minute and followed by maintenance of (50 – 75) ug./kg/minute till achieving Ramsay sedation score of 5 ( patients show sluggish response to light glabellar tap or loud auditory stimulus) and BIS value between (50-70) . all the ERCP procedure time The 1st (P group) received an intravenous propofol loading dose of 1.5mg/kg over 5 minute and followed by maintenance of (50 – 75) ug./kg/minute till achieving Ramsay sedation score of 5 ( patients show sluggish response to light glabellar tap or loud auditory stimulus) and BIS value between (50-70) . 40 Active-Treatment of Control Group
Experimental Group ketofol group The 2nd (KP group) received ketofol which prepared as 1 ml ketamine (50 mg/ml) and 20 ml propofol 1% (10 mg/ml) plus 4 ml normal saline. The mixture was 25 ml by 1:4 and each ml contained 2 mg for ketamine and 8 mg for propofol. Patients was received 1mg/kg of propofol over 5 min and followed by (25 - 50) ug./kg/minute of propofol assuming that mixture contain propofol only. The level of sedation assessed at 1–3 min interval and the infusion rate adjusted to achieve RSS of 5 and BIS from 50 to 70. Both bolus and maintenance doses was given using syringe pump. all ERCP procedure time The 2nd (KP group) received ketofol which prepared as 1 ml ketamine (50 mg/ml) and 20 ml propofol 1% (10 mg/ml) plus 4 ml normal saline. The mixture was 25 ml by 1:4 and each ml contained 2 mg for ketamine and 8 mg for propofol. Patients was received 1mg/kg of propofol over 5 min and followed by (25 - 50) ug./kg/minute of propofol assuming that mixture contain propofol only. The level of sedation assessed at 1–3 min interval and the infusion rate adjusted to achieve RSS of 5 and BIS from 50 to 70. Both bolus and maintenance doses was given using syringe pump. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adult patients aged 18 to 60 years undergoing ERCP • American Society of Anesthesiologists physical status class I-II. • Patients with severe cardiovascular disease. • History of bronchial asthma. • Drug allergy to propofol or ketamine. • History of long term uptake of narcotics, benzodiazepine or any neuropsychiatric medication. • Pregnancy. • Obese patient with body mass index more than 36. • History of any neurological insult. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 23/02/2018 INSTITUTION REVIEW BOARD OF THE NATIONAL LIVER INSTITUTE MENOUFIA UNIVERSITY
Ethics Committee Address
Street address City Postal code Country
YASSIN ABDEL GHAFAR menofia 048123 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Primary aim of the study was to compare propofol and ketofol as a sedative agent regards induction time and recovery time in adult patients undergoing ERCP. second
Secondary Outcome • Secondary aim was to investigate the safety and efficacy of both drugs as regards haemodynamic, respiratory compromise, pain, nausea, vomiting, any psychomimetic effect (Agitation, Irritability…) post procedure patient and endoscopiest satisfaction as well as the total dose of drug consumption. all the ERCP e procedur
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassin abdelghafar street menoufia 0481234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafar menofiya 048123 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute yassin abdel ghafar menofia 048123 Egypt University
COLLABORATORS
Name Street address City Postal code Country
eman 5 abdalah street giza 1234 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman sayed emansayed825@gmail.com 002701282271464 5 abdelah esmaeil nasser elthawara
City Postal code Country Position/Affiliation
giza 1234 Egypt MD
Role Name Email Phone Street address
Scientific Enquiries GASSER ELAZAB g-elazb@l.ver.menofia.edu.eg 01289663992 menofeya
City Postal code Country Position/Affiliation
shebin elkom 048123 Egypt MD
Role Name Email Phone Street address
Public Enquiries HESHAM MAGED heshammaged@yahoo.com 002701223548537 FESAL
City Postal code Country Position/Affiliation
GIZA 1234 Egypt MD
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes because we planed to IPD sharing through any journal PubMed cited Study Protocol immediately after end the study about one month controlled data analysis using SPSS Program for both descriptive and analytic for the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
pubmed 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