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.: PACTR201810868530360 Date of Approval: 29/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Anesthetic technique and oxidative stress during radical mastectomy.
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 Anesthetic techniques might have influential roles in the recurrence rate following breast cancer surgery (1). There is a growing body of evidence that the use of inhaled anesthetics such as sevoflurane has been associated with pro-inflammatory cytokines and increased oxidative stress (2), Contradictory, intravenous propofol has anti-inflammatory and anti-oxidative effects (3). Oxidative stress results from Imbalance between the production of reactive oxygen species (ROS), and their elimination by the antioxidant system. These free oxygen radicals interfere with the new generation of the tissues by affecting DNA and breakage of the single bond and results in exaggerated postoperative inflammatory response that results in delayed wound healing and postoperative morbidities including injuries to the heart, lung, spleen, liver, kidney, red blood cells, and muscles (4) . In normal conditions, free oxygen radicals are maintained at a low level by a varied system of enzymes involved in redox homeostasis in vivo. There are several biomarkers to measure oxidative stress such as the production of malondialdehyde (MDA) and 4-hydroxynoneal (4-HNE), which are well-known biomarkers for lipid peroxidation (5). Additionally, enzymes that can eliminate ROS (e.g. superoxide dismutase (SOD), catalase and glutathione peroxidase (GSH-Px) can be measured. (6). Of note, studies comparing the effects total intravenous anesthesia (TIVA) to sevoflurane on the oxidant/antioxidant system are scarce (7). We hypothesized that, compared with sevoflurane, propofol-based anesthesia during radical mastectomy would be associated with less oxidative stress following radical mastectomy. The present study aimed to compare the effects of propofol and sevoflurane anesthesia on the expression of oxidative stress markers, malondialdehyde and the antioxidant; superoxide dismutase and glutathione peroxidase following radical mastectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2016
Actual trial start date 01/05/2016
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date 15/10/2018
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
Mansoura faculty of medicine - Institutional Research Board
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group sevoflurane sevoflurane of 8% in 92% oxygen for induction of anesthesia, then maintenance with a 0.7-0.9 minimum alveolar concentration (MAC) of sevoflurane. during induction and maintenance of anesthesia till the end of surgery general anesthesia will be induced with an inspired concentration of sevoflurane of 8% in 92% oxygen, then anesthesia was maintained with a 0.7-0.9 minimum alveolar concentration (MAC) of sevoflurane to maintain a bispectral index value between 40-60. 23 Active-Treatment of Control Group
Experimental Group propofol Induction: propofol 2-2.5 mg/kg Maintenance: infusion at a rate of 4-6 mg/kg/h for induction and maintenance of anesthesia till the end of surgery. general anesthesia will be induced with propofol 2-2.5 mg/kg followed with a continuous infusion of propofol at a rate of 4-6 mg/kg/h to keep BIS values between 40-60. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female patients age older than 18 years. who will be scheduled for modified radical mastectomy at the Mansoura University hospitals Significant renal diseases. Significant hepatic diseases. Significant cardiovascular diseases Suggestive history or signs of active inflammatory or infectious diseases. Previous or bilateral breast surgery. Breast reconstruction. Previous chemotherapy. Anemia and blood transfusion during the last 2 weeks. Receiving vitamins and /or antioxidants (folic acid, omega, flavonoids, Vit A, B, C, D, E etc) during the last two months 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Female
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 16/04/2016 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Al Gomhoria street Mansoura 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the perioperative changes in plasma malondialdehyde (MDA) level basal, immeditely after surgery, 24 hoursafter surgery
Secondary Outcome changes in plasma level of glutathione peroxidase (GSH-Px), and superoxide dismutase (SOD) basal, immediately after surgery, 24 hours after surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University hospitals Al Gomhoria street Mansoura 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded. Al Gomhoria street Mansoura 123456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Maysaa El Sayed Zaki Al Gomhoria street Mansoura 123456 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Maysaa El Sayed Zaki Al Gomhoria street Mansoura 123456 Egypt
Mohamed Eslam Said El shehawia Al Gomhoria Mansoura 123456 Egypt
Ahmed Mohamed Farida Al Gomhoria street Mansoura 123456 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maysaa Zaki may_s65@hotmail.com 00201227185777 Al gomhoria Street
City Postal code Country Position/Affiliation
Mansoura 123456 Egypt professor of clinical pathology Mansoura Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed Eslam El shehawia melshehawi@gmail.com 0020100035990 al Gomhoria street
City Postal code Country Position/Affiliation
Mansoura 123456 Egypt Lecturer of anesthesia surgical intensive care and pain management
Role Name Email Phone Street address
Public Enquiries Samah El Kenany sk_20022000@yahoo.com 00201002262557 Hay Al gamaa
City Postal code Country Position/Affiliation
Mansoura 123456 Egypt Lecturer of anesthesia surgical intensive care and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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