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.: PACTR201510001293646 Date of Approval: 04/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of S (+) ketamine on the release of proinflammatory cytokines
Official scientific title Effect of single versus repeated doses of intravenous S (+) ketamine on the release of proinflammatory cytokines in patients undergoing radical prostatectomy.
Brief summary describing the background and objectives of the trial The stimulus of surgery leads to increase in the concentrations of proinflammatory cytokines and altered immune response (1) and radical prostatectomy is a major surgical procedure that is associated a marked inflammatory response and impairment of the immune system which may affect the postoperative outcome. Proinflammatory cytokines modulate pain indirectly through the release of certain substances like nitric oxide, oxygen free radicals and prostaglandins leading to peripheral and central sensitivity and hyperalgesia (2). Excessive production of proin¿ammatory cytokines due to anesthesia and surgical trauma may provoke severe in¿ammatory response and post-operative complications (3). Thus if there is a drug that may be used to decrease the level of proinflammatory cytokines we may achieve more favorable postoperative outcome. Cytokines are low molecular weight proteins which after binding to specific receptors affect immune cell differentiation, proliferation, and activity. Proinflammatory cytokines comprise number of factors like tumor necrosis factor alpha, interleukin 6 and interleukin 8. S (+)-ketamine, the left-handed optical isomer of racemic ketamine, has a fourfold higher affinity for NMDA receptors than its stereoisomer R(¿)-ketamine (4). Investigational trials have reported that this results in an analgesic potency of S(+)-ketamine that is approximately twice that of racemic ketamine (5). The rationale of the study is to evaluate the role of S (+) ketamine in decreasing the unwanted effect of anesthesia and surgery on the immune system (6).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,release of cytokines,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 06/10/2015
Actual trial start date 06/10/2015
Anticipated date of last follow up 10/12/2015
Actual Last follow-up date 10/12/2015
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 radomisation 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
Control Group Group I: received combined epidural-general anesthesia without S (+) ketamine 4 h Group I: received combined epidural-general anesthesia without S (+) ketamine 20 Active-Treatment of Control Group
Experimental Group Group II: received combined epidural-general anesthesia and S (+) ketamine as a single preincision d single dose of 0.25 mg/kg 4 h Group II: received combined epidural-general anesthesia and S (+) ketamine as a single preincision dose 20
Experimental Group Group III: received combined epidural-general anesthesia and S (+) ketamine as preincision and repea repeated doses of ketamine 4 h Group III: received combined epidural-general anesthesia and S (+) ketamine as preincision and repeated doses up to 4 hours of surgery 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I¿II, aged 45-65 years old scheduled for radical cystectomy under combined epidural general anesthesia ASA physical status > ¿I, morbid obesity (body mass index > 35), pre-existing neurological or psychiatric disorders, chronic drug abuse, the use of drugs affecting immunity as chemotherapy or hormonal therapy, uncontrolled diabetics, renal, hepatic, hypertensive patients, contraindication for epidural catheter insertion, hypersensitivity for any anesthetics or drug used. 45 Year(s) 65 Year(s) Male
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 20/08/2015 Anesthesiology department ethical committe
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome release of proinflammatory cytokines baseline, 1, 2, 3, 4, 1h po
Secondary Outcome hemodynamics, pain relief, PONV baseline 1, 2, 3,4 1po
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University hospitals Kasr Al ainy St Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University hospitals, faculty of medicine Kasr Al ainy St Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University hospitals, faculty of medicine Kasr Al ainy St Cairo 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Atef Kamel Salama Kasr Al ainy St Cairo 11562 Egypt
Hassan M Ali Kasr Al ainy St Cairo 11562 Egypt
Hala M Goma Kasr Al ainy St Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Salama atef.kamel@kasralainy.edu.eg +201001155851 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
Role Name Email Phone Street address
Public Enquiries Hassan Ali hassan364@hotmail.com +201001733687 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Atef Salama atef.kamel@kasralainy.edu.eg +201224616643 Kasr Al Ainy St
City Postal code Country Position/Affiliation
Cairo 11562 Egypt MD degree, lecturer of anesthesia, pain and surgical ICU
REPORTING
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