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.: PACTR201408000837224 Date of Approval: 29/05/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intravenous infusion of Ephedrine , Noreadrenaline or a Combination therapy for prophylaxis against hypotension during spinal anaesthesia for cesarean
Official scientific title Intravenous infusion of Ephedrine , Noreadrenaline or a Combination therapy for prophylaxis against hypotension during spinal anaesthesia for cesarean section
Brief summary describing the background and objectives of the trial Hypotension is very common during spinal anaesthesia for caesarean section mounting upto 85%. Several regimens have been described for prophylaxis and treatment with varying success rate . Due to the unavailability of phenylephrine in the egyptian market , noradrenaline was thought of as a substitute for the treatment due to its alpha agonist activity. The aim of the work is :to compare the efficacy of prophylactic therapy with continuous infusion of ephedrine (2 mg/ml), or Noradrenaline group (6ug/ml)or Combination of Noradrenaline (3ug/ml) plus Ephedrine (1mg/ml) initiated directly after conductance of spinal anaesthesia on the incidence of hypotension in healthy pregnant females, American Society of Anesthesiologists (ASA) physical status I , having uncomplicated singleton pregnancy beyond 36 weeks, scheduled to have elective caesarean section under spinal anaesthesia(SA).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Hypotension during spinal anaesthesia,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/06/2014
Actual trial start date
Anticipated date of last follow up 01/11/2014
Actual Last follow-up date
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 randomization Closed envelope technique Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ephedrine group Ephedrine group (2 mg/ml) duration of the surgery continuous infusion 20 Active-Treatment of Control Group
Experimental Group Noradrenaline group (6ug/ml) 60 ml/hr duration of the surgery prophylactic 20
Experimental Group Combination of Noradrenaline (3ug/ml) plus Ephedrine (1mg/ml). 60ml/hr duration of the surgery prophylactic 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy pregnant females, American Society of Anesthesiologists (ASA) physical status I , having uncomplicated singleton pregnancy beyond 36 weeks, scheduled to have elective caesarean section under spinal anaesthesia(SA). ¿ Pregnancy-Induced Hypertension (PIH), ¿ Hypertension, ¿ Cardiac Disease, ¿ Renal Disease, ¿ Foetal Anomaly, ¿ Diabetes Mellitus. 18 Year(s) 40 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
No 01/07/2014 Ethics Committee in the medical Research Institute
Ethics Committee Address
Street address City Postal code Country
Medical Research Institute Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hypotensive episodes recorded as systolic blood pressure less than 90 mmHg every minute until the delivery of the baby Every 2 minutes until the end if the surgery
Secondary Outcome Fetal well-being(APGAR score and umbilical arterial blood gases) APGAR score at 1, 5 min Umbilical arterial blood gases at 2 minutes after delivery
Secondary Outcome Complications -Hypertensive episodes -
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Elshatby maternal University Hospital El-Geish Street , Elshatby Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Elshatby Maternal university Hospital ElGeish street, Elshatby Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute 165, ElHorreya avenue, Elhadara Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Engi Yousry Hashem 165, ElHorreya avenue, Elhadara Alexandria 21561 Egypt
Ahmed Elattar 47, Sultan Hussein street Alexandria 21521 Egypt
Mohamed Elhadidi Alahly Hospital Alexandria 21542 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Engi Hahsem engi.hashem@alex-mri.edu.eg 02 01223372319 165 Elhorreya Street,Elhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anaesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mohamed El Hadidi mmelhadidi@yahoo.com 02 01227498453 3 Dr Borgy , Kafr Abdo, Bolky,
City Postal code Country Position/Affiliation
Alexandria 21549 Egypt lecturer of anaesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elattar a_attar@link.net 0201222144835 47 Sultan Hussein street, Azaritta
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of anaesthesia and surgical intensive care
REPORTING
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