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.: PACTR202110584772902 Date of Approval: 04/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dexmedetomidine for sedation of mechanically ventilated neurocritical care patients after head injury
Official scientific title Safety and efficacy of dexmedetomidine as adjuvant to fentanyl/midazolam combination for sedation of mechanically ventilated neurocritical care patients after head injury: A randomized controlled trial
Brief summary describing the background and objectives of the trial Brain-injured patients may have a high risk of patient–ventilator asynchrony because the respiratory drive and rhythm are controlled by the brainstem neurons as well as the cortical inputs ,It was hypothesized that adding dexmedetomidine to fentanyl/midazolam combination minimizes patient asynchronization during ventilation, reduces straining and coughing, and achieves optimum sedation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Dexmedetomidine in head injury
Disease(s) or condition(s) being studied Anaesthesia,Nervous System Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2021
Actual trial start date 14/09/2021
Anticipated date of last follow up 10/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants)
Recruitment status Active, not 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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control group Fentanyl dose will be 1–3mcg/kg as induction and 0.5–2mcg/kg/h Midazolam dose will be 0.1mg/kg as induction and 0.01-0.2mg/kg/hr as maintenance of sedation placebo (saline) infusion After 48 hrs. of initiation of the drugs and sedation. 19, adult, male and female, mechanically-ventilated, neurocritical care patients after acute head injury will receive fentanyl/midazolam combination as sedation 19 Placebo
Experimental Group Dexmedetomidine group Fentanyl dose i will be 1–3mcg/kg as induction and 0.5–2mcg/kg/h as maintenance Midazolam dose will be 0.1mg/kg as induction and 0.01-0.2mg/kg/hr as maintenance and Dexmedetomidine dose will be 1mcg/kg as loading and 0.42–1mcg/kg/h as maintenance of sedation. After 48 hrs of initiation of the drugs and sedation. 19, adult, male and female, mechanically-ventilated, neurocritical care patients after acute head injury will receive dexmedetomidine/fentanyl/midazolam combination 19
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 18 - 70 years-old GCS: 8 - 12 at the time of admission Severe head injury (GCS less than 8) 2. Any previous neurological insult 3. Severe brain edema or brain hemorrhage with midline shift 4. Severe polytrauma 5. Advanced liver or kidney disease 6. Uncontrolled diabetes, hypertension, or heart disease 7. History of chronic use of sedatives, narcotics, alcohol, or drug abuse Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 28/08/2021 Ain shams research ethics committee
Ethics Committee Address
Street address City Postal code Country
alabassia, cairo cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The number of patient-ventilator asynchrony per day After 48 hrs. of initiation of the drugs and sedation
Secondary Outcome Level of sedation by the RASS score. 2. Mean arterial blood pressure. 3. Heart rate. 4. Respiratory rate. 5. Exhaled tidal volume. 6. End tidal CO2. 7. Duration of mechanical ventilation. 8. The NCCU duration of stay. Either Improvement of the patient and extubation, mortality or occurrence of complication from the drugs used in sedation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospitals 38 elabassia cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
amr sobhy mohammed kamal walaa elsabeeny mostafa ibrahim elmakwleen elarab -elnozha cairo 11843 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor amr sobhy elmakwleen elarab-elnozha cairo 11843 Egypt self fund
COLLABORATORS
Name Street address City Postal code Country
mohammed kamal naser city cairo 11759 Egypt
walaa elsabeeny naser city cairo 11759 Egypt
mostafa ibrahim naser city cairo 11759 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr sobhy dr.amrsobhy2013@gmail.com 00201063394383 elmakwleen elarab
City Postal code Country Position/Affiliation
cairo 111843 Egypt associated professor at ain shams university department of anesthesia intensive care and pain management
Role Name Email Phone Street address
Scientific Enquiries bahaa ewiss bahaaew@yahoo.com 00201222406018 naser city
City Postal code Country Position/Affiliation
cairo Egypt professor at ain shams university department of anesthesia intensive care and pain management
Role Name Email Phone Street address
Public Enquiries walaa elsabeeny walaa.elsabeeny@nci.cu.edu.eg 00201007798466 naser city
City Postal code Country Position/Affiliation
cairo Egypt lecturer at national cancer institute cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes excel sheet for data Statistical Analysis Plan,Study Protocol within 12 month Editors of journal to be submitted
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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