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.: PACTR202007774954789 Date of Approval: 17/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Co-sedative during brain tumor anaesthesia
Official scientific title Lidocaine versus magnesium sulphate infusion during isoflurane brain tumor anaesthesia, effect on minimum alveolar concentration reduction guided by bispectral index: prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Brain tumour surgery usually is carried out with the patient under general anaesthesia. Early and rapid emergence from anaesthesia is desirable in most neurosurgical patients for early screening of potential complications. In such long surgeries, using of co-sedatives and anaesthetic drugs reduction is highly effective
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MAC
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 04/07/2020
Actual trial start date
Anticipated date of last follow up 04/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 magnesium sulphate infusion Patients will receive 30mg /kg magnesium loading dose over 10 min. followed by 10 mg/kg/h. intraoperative Patients will receive 30mg /kg magnesium loading dose over 10 min. followed by 10 mg/kg/h. 25
Control Group lidocaine infusion Patients will receive 1.5 mg/kg lidocaine loading dose over 10 min. followed by 1.5 md/kg/h. intaoperative Patients will receive 1.5 mg/kg lidocaine loading dose over 10 min. followed by 1.5 md/kg/h. 25 Active-Treatment of Control Group
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-18 Year,Adult: 19 Year-44 Year,Aged: 65+ 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 03/07/2020 IRB mansoura university
Ethics Committee Address
Street address City Postal code Country
elgomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome minimum alveolar concentration reduction 0,15,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240,270,300 min. intraoperativ e
Secondary Outcome richmond agitation sedation scale 0h, postoperative
Secondary Outcome VAS score 0,1,2,4,6 h.postoperative
Secondary Outcome total muscle relaxant dose, recovery time 0 h. post operative
Secondary Outcome HR, MABP, Spo2, end tidal Co2 , bispectral index 0,15,30,45,60,75,90,105,120,135,150,165,180,195,210,225,240,270,300 min intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed adel abouelela khattab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine 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 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia and SICU
Role Name Email Phone Street address
Public Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia and SICU
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anaesthesia and SICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study desigm, methods, 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