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.: PACTR201810518426098 Date of Approval: 30/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Usage of ephedrine, norepinephrine and phenylephrine infusions to preventing A comparative hypotension in caesarian section(CS)
Official scientific title Comparative study between of ephedrine, norepinephrine and phenylephrine infusions to prevent spinal hypotension during cesarean section
Brief summary describing the background and objectives of the trial This study is comparing the effect of ephedrine, norepinephrine and phenylephrine infusions in preventing post spinal hypotension and compare their effects on neonatal APGAR score, maternal nausea & vomiting during spinal anesthesia with the three infusions
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 13/10/2018
Actual trial start date 13/10/2018
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date 31/10/2019
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phenylephrine group A 0.1 ug/kg/min Just after receiving spinal anesthesia to the end of surgery intravenous infusion using a syringe pump 25
Experimental Group Nor epinephrine 0.05 ug/kg/min Just after receiving spinal anesthesia to the end of surgery intravenous infusion using a syringe pump 25
Control Group Ephedrine 1mg/min. Just after receiving spinal anesthesia to the end of surgery intravenous infusion using a syringe pump 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I-II pregnant women, singleton gestation, >36 weeks, scheduled for elective cesarean section under regional anesthesia. women who refuse to participate in the study, women with preeclampsia, eclampsia, cardiac patients, asthmatic patients any systemic diseases, patients with coagulation defects that contraindicate spinal anesthesia Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 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
Yes 04/02/2018 anesthesia department of menoufia university hospitals.
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparing the effect of ephedrine, norepinephrine and phenylephrine infusions in preventing post-spinal hypotension MAP Before administration of the vasopressor drug as baseline values, Before induction of spinal anesthesia, At 5 minutes intervals all through the surgery
Secondary Outcome compare their effects on neonatal APGAR score, maternal nausea & vomiting Incidence of intraoperative complications as Nausea and vomiting, incidence of fetal acidosis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospitals Yasin Abd Elghafar Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine menoufia university hospitals 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr Nadia Mohee Eldin Bahgat Mohammed Husseini street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Mohammed Ahmed f.sabry60@yahoo.com 00201017590580 13 Elnaser street
City Postal code Country Position/Affiliation
Sohag 002067 Egypt Resident of Anesthesiology in general Sohag health hospital
Role Name Email Phone Street address
Principal Investigator Nadia Mohee Eldin Bahgat dr_nmbahgat@yahoo.com 00201009558238 Mohammed Husseini street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Lecturer of anesthesia and intensive Care Menoufia University.
Role Name Email Phone Street address
Public Enquiries Ashraf Eskander ameskander@yahoo.com 00201001960697 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant professor of anesthesia and intensive Care Faculty of Medicine Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Hatem Amen Atalla Hatattalla@hotmail.com 00201001445568 Al Bahari street
City Postal code Country Position/Affiliation
Alexandria 002003 Egypt Professor of anesthesia and intensive Care Faculty of Medicine Menoufia University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes age, weight, height, blood pressure, pulse, spinal level, Bromage score, consumption of vasopressors, time of operation, fetal ABGAR score. Informed Consent Form,Statistical Analysis Plan,Study Protocol October 2018 to October 2019 ephedrine, norepinephrine phenylephrine, infusions, spinal hypotension, cesarean section
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