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.: PACTR201803003203136 Date of Approval: 15/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safety and efficacy of dexmedetomidine, ketofol and propofol for sedation of mechanically ventilated patients
Official scientific title Safety and efficacy of dexmedetomidine, ketofol and propofol for sedation of mechanically ventilated patients in intensive care unit
Brief summary describing the background and objectives of the trial Critically ill patients in an intensive care unit (ICU) are subjected to a variety of noxious stimuli including pain after surgery, frequent venipuncture, invasive monitoring and endotracheal intubation .[1]The ideal sedative should be effective, short-acting and non-cumulative, free of adverse effects, having rapid onset and offset, with no effect on the metabolism of other drugs and lastly should have known pharmacokinetics and pharmacodynamics in organ failure. The drugs commonly used for sedation in the ICU include benzodiazepines, antipsychotic and propofol
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied mechanically ventilated patients in the intensive care unit.,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/11/2015
Actual trial start date 21/11/2015
Anticipated date of last follow up 21/11/2017
Actual Last follow-up date 21/11/2017
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
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 closed sealed opaque envelops: closed sealed opaque envelops: Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group1: 30 patients will receive ketofol an initial bolus dose (500mcg/kg) of ketamine/propofol1:1 ( Group1: 30 patients will receive ketofol an initial bolus dose (500mcg/kg) of ketamine/propofol1:1 (ketamine 8 mg/ml and propofol 8 mg/ml) followed by a maintenance dose of (10 mcg/kg/min) and the in Group1: 30 patients will receive ketofol an initial bolus dose (500mcg/kg) of ketamine/propofol1:1 (ketamine 8 mg/ml and propofol 8 mg/ml) followed by a maintenance dose of (10 mcg/kg/min) and the in Group1: 30 patients will receive ketofol an initial bolus dose (500mcg/kg) of ketamine/propofol1:1 (ketamine 8 mg/ml and propofol 8 mg/ml) followed by a maintenance dose of (10 mcg/kg/min) and the infusion dose adjusted (in 5mcg/kg/min increment 30
Experimental Group Group2: 30 patients will receive loading dose infusion of dexmedetomidin (precedex ) diluted in 0. Group2: 30 patients will receive loading dose infusion of dexmedetomidin (precedex ) diluted in 0.9% sodium chloride 1mcg /kg/h over10 min followed by a maintenance infusion of 0.2-0.7mcg/kg/h Group2: 30 patients will receive loading dose infusion of dexmedetomidin (precedex ) diluted in 0.9% sodium chloride 1mcg /kg/h over10 min followed by a maintenance infusion of 0.2-0.7mcg/kg/h Group2: 30 patients will receive loading dose infusion of dexmedetomidin (precedex ) diluted in 0.9% sodium chloride 1mcg /kg/h over10 min followed by a maintenance infusion of 0.2-0.7mcg/kg/h 30
Experimental Group Group3: 30 patients will receive Propofol (diprivan) undiluted as an infusion of 1-3mg/kg/h, after a Group3: 30 patients will receive Propofol (diprivan) undiluted as an infusion of 1-3mg/kg/h, after a loading dose infusion up to1mg/kg over10 min Group3: 30 patients will receive Propofol (diprivan) undiluted as an infusion of 1-3mg/kg/h, after a loading dose infusion up to1mg/kg over10 min Group3: 30 patients will receive Propofol (diprivan) undiluted as an infusion of 1-3mg/kg/h, after a loading dose infusion up to1mg/kg over10 min 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Adult patients(18yr or older) ¿ The patients whose will require a minimum of 24h artificial ventilation after complex major surgery ¿ The patients need for sedation ¿ Patients with increased intracranial tension ¿ Patients with known allergies to the studied Drugs 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 10/11/2015 fm-bsurec
Ethics Committee Address
Street address City Postal code Country
Beni-Suef governerate Beni-Suef governerate 11391 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ramsay Sedation Scale 1,6,12,18,24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef University hospital Beni-Suef Beni-Suef 11391 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zeinab Taha Mohammed Beni-Suef Beni-Suef 11391 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Zeinab Taha Mohammed Beni-Suef Beni-Suef 11391 Egypt
Hatem Elmoutaz Beni-Suef Beni-Suef 11391 Egypt
samaa rashwan Beni-Suef Beni-Suef 11391 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zeinab Mohammed doaa_rashwan@hotmail.com 01011270763 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 11391 Egypt Assistant lecturerrFaculty of medicine, Beni Sueif University
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 01011270763 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 11391 Egypt Assistant professor Faculty of medicine, Beni Sueif University
Role Name Email Phone Street address
Scientific Enquiries samaa rashwan doaa_rashwan@hotmail.com 01011270763 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef 11391 Egypt Assistant professor Faculty of medicine, Beni Sueif University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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