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.: PACTR202003536095702 Date of Registration: 12/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diuretic regimens in brain tumor surgery
Official scientific title Low dose mannitol with furosemide versus ordinary mannitol dose to reduce intracranial pressure in supra tentorial brain tumor surgery: comparative study
Brief summary describing the background and objectives of the trial Brain tumor associated with raised intracranial pressure, diuretics and osmotherapy can reduce this elevation. Drugs doseing and side effects varying greatly. We are trying to reach least effective dose to reduce raised ICP dependig on ONSD to reduce side effect of these drugs
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ONSD
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/03/2020
Actual trial start date
Anticipated date of last follow up 06/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
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
Experimental Group Low dose mannitol with furosemide manitol 0.25 g/kg furosemide 0.5 mg/kg intraoperative: mannitol over 15 min furosemide over 30 min after anaesthesia induction and intubation, patients of this group will receive 0,5 mg/kg furosemide over 30 min with starting surgical skin incision patients will start receiving manitol 0.25 g/kg over 15 min 30
Control Group ordinary mannitol dose mannitol 1g/kg intraoperative: over 15 min after anaesthesia induction,intubation and possitioning, with starting skin incision 1 g/kg mannitol will be given over 15 min 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults both sex ASA I or II aging 18-65 years undergoing supra tenttorial brain tumor surgery in mansoura university hospitals. 1-Patient refusal 2-Major cardiopulmonary disorders 3-Hepatic or renal disorders 4-Allergy to used drugs. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 26/02/2020 IRB mansoura university
Ethics Committee Address
Street address City Postal code Country
el gomhoria elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome optic nerve sheath diameter 0,15,45 min--basal, after diuretics infusion end, 30 min after dura opening
Secondary Outcome brain relaxation score--- BRS--(1=very good, 2=good, 3=bad, 4=very bad) 20, 50 min----immediate after dura opening, 30 min later----
Secondary Outcome HR, MABP, Spo2, end tidal Co2 o,5,10,15,20,50 min
Secondary Outcome urine output, Na,k, serum lactate 60 min
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital el-gomhoria street mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed abouelela khatab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university egypt elgomhoria street elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoua university egypt
Role Name Email Phone Street address
Public Enquiries mohamed abouelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khatab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia mansoura university egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study design, methodolgy, results Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 month after completion of study through IRB mansoura university
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