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.: PACTR202008567047887 Date of Approval: 25/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Neuroprotective effect of dexmedetomidine in brain tumor surgery
Official scientific title Evaluation of neuroprotective effect of dexmedetomidine in patients undergoing brain tumor resection‏
Brief summary describing the background and objectives of the trial Dexmedetomidine is a highly selective α2- adrenoceptor agonist, which is commonly used in clinic as an adjuvant anesthesia that has effects of sedation, analgesia, and anti-anxiety. For acute craniocerebral injury, the application of dexmedetomidine could suppress perioperative inflammatory response and protect cerebral function at certain level. In animal models of cerebral ischemia injury, Dexmedetomidine was also confirmed to possess the ability of reduce the concentrations of brain damage markers, such as S100β protein The aim of our study is to evaluate the neuro-protective effect of dexmedetomidine in patients undergoing brain tumor surgeries
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/08/2020
Actual trial start date
Anticipated date of last follow up 15/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 total intravenous anesthesia propofol intravenous infusion (50-200 µgm/kg/min) , and fentanyl 1 µgm/kg/h during the whole duration of the surgery total intravenous anesthesia for the whole duration of surgery 20 Placebo
Experimental Group dexmedetomidine dexmedetomidine 0.5µgm/kg bolus dose will be given over 10 minutes before induction of anesthesia followed by 0.1-0.5 µgm/kg/h continuous infusion until the end of surgery the whole duration of the surgery dexmedetomidine intravenous infusion added to total intravenous anesthesia (by propofol and fentanyl as control group) bolus dose end before induction of anesthesia and continuous infusion during the whole duration of the surgery 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients aged 20-60 years, both sex, ASA class I and II, who undergo elective supratentorial tumor resection surgery patient's refusal, pre-existing psychiatric disorders or cognitive dysfunction, cerebral infarction, frontal lesions A-V heart block, patients who need intraoperative blood transfusion or those who need postoperative mechanical ventilation surgery in prone position. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 26/04/2020 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
El Geish St Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cerebral oxygen extraction ratio preoperative baseline value, every one hour intraoperative, then 6, 12 hours postoperative.
Secondary Outcome cognitive function before operation, then 6 and 24 hours postoperative
Secondary Outcome hemodynamic changes heart rate and mean arterial pressure baseline ,after end of bolus dose of the study drug or placebo, immediately after intubation, every 30 min till the end of surgery
Secondary Outcome complications e.g. PONV, hypotension , bradycardia intraoperative upto 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine El Geish St Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors Dr Mona Elghamry Dr Mohammad Abduallah Dr Mohamed Afandy El Geish St Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mona Raafat Elghamry El Geish St Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohammad Ali Abduallah El Geish St Tanta 31527 Egypt
Mona Raafat Elghamry El Geish St Tanta 31527 Egypt
Mohamed Elsayed Afandy El Geish St Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Abduallah Moh_aly_2005@hotmail.com +201099957971 El Geish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mohamed Afandy mohamedafandy811@yahoo.com +201225131526 El Geish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Mona Elghamry drmonagh19802000@gmail.com +201060101867 El Geish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of oxygen extraction ratio, cognitive function, haemodynamics, and side effects Statistical Analysis Plan IPD will be shared after finishing and publication of the study.and it will be available for 6 months. the IPD will be available for those who are interested in neuroanesthesia up on e-mail request. request will be sent to the following e-mail ( drmonagh19802000@gmail.com )
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