Home
 


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: www.pactr.org

Trial no.: PACTR201304000509378 Date registered: 2013/02/23
TRIAL DESCRIPTION
Public title Serum IL-6 level in breast cancer surgery: evaluating the addition of hydrocortisone on two anaesthetic regimens
Official scientific title Serum IL-6 level in breast cancer surgery: evaluating the addition of hydrocortisone on two anaesthetic regimens
Brief summary describing the background
and objectives of the trial
part I of the study, patients randomly allocated to one of two study groups, in the period of March 2013 to end of May 2013.group I receives hydrocortisone with standard anesthesia, while group II serves as placebo. in Part II of the study random allocation of patients to two groups in the period of June 2013 to end of August 2013. Two groups receive hydrocortisone but with two different anaesthetic techniques. Aiming to define best anaesthetic technique to lower IL-6 using hydrocortisone
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2013-03-02
Actual trial start date 2013-03-02
Anticipated date of last follow up 2013-08-31
Actual date of last follow up 2013-08-31
Anticipated target sample size (number of participants) 100   
Actual target sample size (number of participants) 100   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised simple randomisation using statistic random tables sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group hydrocorstisone 100 mg , on induction and two hours later two doses at induction o anaesthesia and two hours later 50
Control group placebo saline two doses at induction o anaesthesia and two hours later 50 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
ASA I-II women who undergo conservative breast cancer surgery Patients with endocrine or metabolic disorders, diabetes, obesity (Body Mass Index >30 kg/m2), history of CNS diseases and patients under current or recent medication affecting the sympathetic response or the hormonal secretion were excluded from the study. 20 Years 60 Years 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 2013/04/24 medical research institute committee
Ethics Committee Address
Street address City Postal code Country
165 horreya street Alexandria 21561 Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome decrease level of IL-6 IL-6 preoperative 6hours after surgery 24 hour postoperative
Secondary Outcome type of anaesthesia possibly affecting IL-6 PART II of the study, comparing two anaesthetic regimens , while adding hydrocortisone to each

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
authors involved 165 Horreya road- Alhadara Alexandria 21561 Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt Hospital

COLLABORATORS
Name Street address City Postal code Country
Medical Research Institute 165 Horreya road- Alhadara Alexandria 21561 Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Sherif Abdelhamid dr_shereif@hotmail.com 00201001459756
Street address City Postal code Country Position / Affiliation
165 horreya road alexandria 21561 Egypt Lecturer
Role Name Email Phone Fax
Scientific Enquiries Dr Salwa hamdy salwa.hamdi74@yahoo.com 002034284659
Street address City Postal code Country Position / Affiliation
165 horreya road alexandria 21561 Egypt Lecturer og chemical pathology
Role Name Email Phone Fax
Public Enquiries Dr Ahmed Talha dr_shereif@hotmail.com 00201001459756
Street address City Postal code Country Position / Affiliation
165 horreya road alexandria 21561 Egypt Lecturer of surgery