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.: PACTR201604001579155 Date of Approval: 11/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Oxidative Stress in Patients Undergoing Modified Radical Mastectomy Under Sevoflurane compared to Total Intravenous Anesthesia
Official scientific title Oxidative Stress in Patients Undergoing Modified Radical Mastectomy Under Sevoflurane compared to Total Intravenous Anesthesia
Brief summary describing the background and objectives of the trial During the surgical and anesthetic trauma, nitric oxide (NO) productions have been reported to change. NO is produced in the vascular endothelium from l arginine as a response to physical and receptor stimulation, by nitric oxide synthase (NOS) which is known to be a calcium/calmodulin-dependent enzyme. NO is a radical compound due to having a single unmatched electron inits outer shell. It is not toxic in low concentrations. While NO plays an important role in the management of cardiovascular function, neurotransmission, and blood pressure, it also bears importance with regard to immune system (5).Volatile agents have been reported to inhibit endothelialand neuronal NOS by way of inhibiting intracellular calcium Mobilization (5) Aim of the study To compare the levels of NO production in patients undergoing modified radical mastectomy under sevoflurane compared to total intravenous anesthesia
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2016
Actual trial start date 07/02/2016
Anticipated date of last follow up 02/07/2016
Actual Last follow-up date 02/07/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 randomisation using a randomisation 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
Experimental Group total intravenous group ¿TIVA group 4-6 mg/kg/h throughout the surgical time General anesthesia will be induced in by propofol 2-2.5 mg/kg.General anesthesia will be maintained by continuous infusion of propofol at rate of 4-6 mg/kg/h to keep Bispectral index value between 40-60. O2- air mixture (40-60%) will be used during mechanical ventilation. 30
Experimental Group sevoflurane group General anesthesia will be maintained by sevoflurane 2-3% in O2- air mixture (40-60%) throughout the surgical time general anesthesia will be induced by using sevoflurane at inspired concentration of 2% in 100 % O2 for 30 seconds then inspired concentration of sevoflurane will increased to 8% till the bispectral index value become less than 60 then inspired concentration of sevoflurane decreased to 3%. General anesthesia will be maintained by sevoflurane 2-3% in O2- air mixture (40-60%), to keep Bispectral in 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients above the age of 18 years, ASA I-II undergoing modified radical mastectomy Patients with renal dysfunction, hepatic dysfunction, cardiovascular diseases inflammatory diseases 18 Year(s) 75 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 03/04/2016 Mansoura Faculty of Medicine, MFM-IRB
Ethics Committee Address
Street address City Postal code Country
Mansoura- Mansoura Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome serum nitric oxide at the start of anaesthesia and after 24 hours
Secondary Outcome total antioxidant at the start of anaesthesia and after 24 hours
Secondary Outcome postoperative complications postoperative
Secondary Outcome hospital stay postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals algeish Tanta 31512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
our study will not depend on funding tanta 31512 Egypt
no source of funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed M Abu Elyazed Algeish Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Essam Eldin algeish Tanta 31512 Egypt
Maysaa Elsayed Zaki Mansoura Mansoura Egypt
Maha Mahmoud Hagras Algeish Tanta Egypt
Mohamed M Abu Elyazed Algeish Tanta 31512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abu Elyazed mohd_yazed75@yahoo.com 0020403462350 algeish
City Postal code Country Position/Affiliation
tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, tanta university
Role Name Email Phone Street address
Public Enquiries Ahmed Essam Eldin madamada6@gmail.com 00201001802978 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abu Elyazed mohd_yazed75@yahoo.com +20403462350 algeish street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer of anesthesiology and surgical intensive care, Tanta university
REPORTING
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