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.: PACTR202110875547798 Date of Approval: 27/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF SEVOFLURANE VERSUS PROPOFOL ON COGNITIVE FUNCTIONS IN ELDERLY PATIENTS
Official scientific title EFFECT OF SEVOFLURANE VERSUS PROPOFOL ON EARLY COGNITIVE FUNCTIONS IN ELDERLY PATIENTS AFTER LUMBAR DISC SURGERY
Brief summary describing the background and objectives of the trial The present prospective study aims to compare the effects of propofol based anaesthesia versus sevoflurane based anaesthesia on early cognitive functions in elderly patients scheduled for lumbar disc surgery under general anaesthesia. Primary outcome is: Incidence of cognitive dysfunction 120 minutes and 24 hours postoperatively. Secondary outcome is: • The changes of serum level of S100 beta as a measure of neuronal damage and to correlate the association between S100 beta serum level and incidence of postoperative cognitive dysfunction. • Haemodynamic status. • Use of vasoactive drugs
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Musculoskeletal Diseases,Nervous System Diseases,Surgery
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
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet 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 Sevoflurane 1.5 - 2 % for the entire duration of surgery Minimum Alveolar Concentration (MAC) of sevoflurane will be adjusted according to the haemodynamic variables and entropy values maintaining state entropy (SE) and response entropy (RE) values between 40 and 60. 60
Control Group Propofol at a rate of 6-8 mg kg–1 h–1 for the entire duration of surgery in group with propofol infusion at a rate of 6-8 mg kg–1 h–1. Infusion rate of propofol will be adjusted according to the haemodynamic variables and entropy values maintaining state entropy (SE) and response entropy (RE) values between 40 and 60. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: Patients with American Society of Anesthesiologists score of I–II, of both sex, age 65 years or older, have a sufficient level of education to be capable of completing neuropsychological tests, do not have serious hearing or vision impairment and are able to read. Exclusion criteria: 1. Patient’s refusal. 2. ASA III/IV. 3. Mini Mental State Examination (MMSE) score less than 26. 4. Patients with severe hepatic, renal or cardiovascular disease. 5. Pre-existing neurological, dementia or neuropsychological disease 6. Current use of sedatives, antidepressants or corticosteroids 7. History of cerebral surgery or recent stroke. 8. History of alcohol abuse or drug addict. 9. Intraoperative events requiring interventions not included in the study protocol such as excessive blood loss and severe hypotension. Aged: 65+ Year(s) 65 Year(s) 99 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 12/05/2021 Ethics Committee Faculty of medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El-Massallah, Alexandria, Egypt Alexandria 21675 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome is: Incidence of cognitive dysfunction 120 minutes and 24 hours postoperatively. 120 minutes and 24 hours postoperatively.
Secondary Outcome Secondary outcome is: • The changes of serum level of S100 beta as a measure of neuronal damage and to correlate the association between S100 beta serum level and incidence of postoperative cognitive dysfunction. • Haemodynamic status. • Use of vasoactive drugs 120 minutes and 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospitals Faculty of Medicine Faculty of medicine, Alexandria university 17 Champollion Street, El-Massalah Alexandria Egypt Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 26 Ain ElHayah Street, Sporting, Alexandria, Egypt Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anesthesia and surgical ICU Faculty of medicine Alexandria University Faculty of medicine alexandria University, 17 Champollion street El-Massallah, Alexandria, Egypt Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehab Darwish ehabdarwish152@gmail.com 00201002860921 26 Ain ElHayah Street, Sporting, Alexandria, Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant Lecturer of Anesthesia and surgical ICU Faculty of medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Sherif ElHadi selhadi@hotmail.com 00201222185437 Faculty of medicine Alexandria University, 17 Champollion Street, El-Massallah, Alexandria Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Anesthesia and surgical ICU Alexandria University
Role Name Email Phone Street address
Public Enquiries Rania Abo Elfetouh raniaaboelfetouh@gmail.com 00201001394019 Faculty of medicine, Alexandria University, 17 Champollion Street, EL-Massallah, Alexandria Egypt
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia and Surgical ICU Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will upload the IPD sheet once the all study participants approve their participation in the trial and sign their informed consents Study Protocol within 2 year of registration Controlled data
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