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.: PACTR201505001095139 Date of Approval: 02/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative effect of propofol versus sevoflurane on renal ischemia/reperfusion injury after elective open abdominal aortic aneurysm repair. A random
Official scientific title Comparative effect of propofol versus sevoflurane on renal ischemia/reperfusion injury after elective open abdominal aortic aneurysm repair. A randomized trial
Brief summary describing the background and objectives of the trial Purpose: Renal injury is a common cause of morbidity and mortality after elective abdominal aortic aneurysm (AAA) repair. Propofol has been reported to protect several organs from ischemia-reperfusion (I/R) induced injury. We performed a randomized controlled trial to compare propofol and sevoflurane for their effects on renal I/R injury in patients undergoing elective AAA repair. Materials and methods: Fifty patients scheduled for elective AAA repair were randomized to receive propofol anesthesia in group I or sevoflurane anesthesia in group II. Urinary specific kidney proteins (N-acetyl-beta-Dglucosamidase, alpha-1-microglobulin, glutathione transferase-pi, glutathione transferase-alpha) were measured within 5 min of starting anesthesia as a base line (T0), at the end of surgery (T1), 8h after surgery (T2), 16h after surgery (T3) and 24 h postoperatively (T4). Serum pro-inflammatory cytokines (tumor necrosis factor-¿ and interleukin 1-¿) were measured at the same time points. In addition, serum creatinine and cystatin C were measured before starting surgery as a baseline, and at days 1, 3, 6 after surgery. Results: Postoperative urinary concentrations of all measured kidney specific proteins and serum pro-inflammatory cytokines were significantly lower in the propofol group. In addition, the serum creatinine and cystatin C were significantly lower in the propofol group compared with the sevoflurane group. Conclusion: Propofol significantly reduced renal injury after elective open AAA repair and this could have clinical implications in situations of expected renal I/R injury. Keywords: propofol; renal ischemia-reperfusion injury; sevoflurane
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied renal ischemia/reperfusion injury,Anaesthesia,Circulatory System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial propofol versus sevoflurane
Anticipated trial start date 05/02/2012
Actual trial start date 05/02/2012
Anticipated date of last follow up 10/04/2014
Actual Last follow-up date 10/04/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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 using a random number table generated by Microsoft Excel The patients were randomly allocated to receive propofol (n=25) or sevoflurane (n=25) anesthesia using a random number table generated by Microsoft Excel. An independent statistician was assigned to perform central randomization to ensure proper concealment of the study management from the patients and investigators until the release of the final statistical results. 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 propofol group general anesthesia was induced with propofol 1.5¿2 mg/kg Anesthesia was maintained with a continuous infusion of propofol 4-6 mg. kg-1. h-1 In the propofol group, general anesthesia was induced with propofol 1.5¿2 mg/kg and fentanyl 3µg/kg . Tracheal intubation was facilitated by administration of cis-atracurium 0.1 mg/kg. Anesthesia was maintained with a continuous infusion of propofol 4-6 mg. kg-1. h-1, and cis-atracurium 2 µg. kg-1. min-1. 25
Experimental Group sevoflurane group anesthesia was induced as above but maintained with sevoflurane 1MAC anesthesia was induced as above but maintained with sevoflurane 1MAC In the sevoflurane group, anesthesia was induced as above but maintained with sevoflurane 1MAC and cis-atracurium 2 µg. kg-1. min-1. The bispectral index electrode (BIS-Sensor, Aspect Medical Systems, USA) was positioned on the patient's forehead to monitor depth of anesthesia where BIS value was kept between 45-55 in both groups through modulating propofol infusion rate or sevoflurane concentrat 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
50 ASA class II or III patients scheduled for elective infra-renal AAA repair. Patients were excluded from the study if they needed concomitant procedures other than AAA repair, had experienced an acute coronary syndrome within 3 months, or were >85 years of age. 65 Year(s) 85 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 20/01/2012 Ethical committee of Minoufiya Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Urinary specific kidney proteins (N-acetyl-beta-Dglucosamidase, alpha-1-microglobulin, glutathione transferase-pi, glutathione transferase-alpha) were measured within 5 min of starting anesthesia as a base line (T0), at the end of surgery (T1), 8h after surgery (T2), 16h after surgery (T3) and 24 h postoperatively (T4).
Primary Outcome creatinine clearance and serum cystatin before starting surgery as a baseline, and at days 1, 3, 6 after surgery
Secondary Outcome Serum pro-inflammatory cytokines (tumor necrosis factor-¿ and interleukin 1-¿) were measured within 5 min of starting anesthesia as a base line (T0), at the end of surgery (T1), 8h after surgery (T2), 16h after surgery (T3) and 24 h postoperatively (T4)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 3Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany S Ammar 2Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
khaled mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201224884620 3Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya University, Egypt
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 3Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya University, Egypt
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 3Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya University, Egypt
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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