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.: PACTR202003466791077 Date of Approval: 23/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Norepinephrine as an Alternative in Hypotension Prophylaxis During Cesarean Section under Spinal Anesthesia
Official scientific title Comparative study of Norepinephrine and Ephedrine for prophylaxis against Hypotension during Spinal Anesthesia for Cesarean Section
Brief summary describing the background and objectives of the trial Spinal anesthesia is the preferred method for elective cesarean sections (C.S.) due to considerable risks regarding airway management associated with physiological changes of pregnancy. Hypotension is reported to occur in up to 80% of spinal anesthesia cases. Many approaches have been investigated to prevent spinal hypotension, e.g., fluid loading, vasopressors, or both. Thus we compare the administration of intermittent I.V. boluses of norepinephrine and ephedrine to guard against the hypotensive effect of spinal anesthesia during cesarean delivery.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/10/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date 29/02/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ephedrine Group bolus of I.V. ephedrine 20 mg Single dose. On arrival to the theater, standard monitoring was applied to all patients (ECG, non-invasive blood pressure and pulse oximetry) and a wide pore 18-G I.V. cannula was inserted into a suitable vein to infuse 500 ml Ringer’s solution as a preload to all patients before starting to commence the spinal anesthesia procedure. Spinal anesthesia was performed using spinal needle of 25-G or smaller, under complete aseptic conditions. Patients received a prophylactic bolus of I.V. ephedrine 20 mg at the time of intrathecal block. 60 Active-Treatment of Control Group
Experimental Group Norepinephrine Group bolus of norepinephrine 16 μg intravenous (I.V.) at the time of intrathecal block. single dose. On arrival to the theater, standard monitoring was applied to all patients (ECG, non-invasive blood pressure and pulse oximetry) and a wide pore 18-G I.V. cannula was inserted into a suitable vein to infuse 500 ml Ringer’s solution as a preload to all patients before starting to commence the spinal anesthesia procedure. Spinal anesthesia was performed using spinal needle of 25-G or smaller, under complete aseptic conditions. Patients received a prophylactic bolus of norepinephrine 16 μg intravenous (I.V.) at the time of intrathecal block. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients within age raged from 21-35 years Physical status ASA II undergoing elective C.S. Females with a known history of allergy to any of the study drugs Females with bleeding disorders Females with vertebral anomalies Females with neurological deficits Adult: 19 Year-44 Year 21 Year(s) 35 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 18/09/2019 Research Ethics Committee faculty of medicine ain shams university FAW 000017585
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt. Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The number and total dose of the boluses of vasopressors to treat maternal hypotension (reduction in systolic blood pressure more 20% from baseline) 60 minutes after spinal anesthesia
Secondary Outcome Mean blood pressure (MBP) every 2 minutes after spinal injection until delivery of the baby and then every 5 minutes till the end of the study period were recorded
Secondary Outcome heart rate (HR) every 2 minutes after spinal injection until delivery of the baby and then every 5 minutes till the end of the study period
Secondary Outcome Uterine artery pulsatility index (UtA-PI) , umbilical artery pulsatility index (UA-PI) baseline and 5 minutes after spinal anesthesia.
Secondary Outcome Neonatal Apgar Score 1 and 5 minutes, after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Ramsis street, Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Hospitals Ramsis street, Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Ramsis street, Abbasia Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Ibrahim Elsayed Shahin Department of Anesthesiology, Intensive Care Cairo Egypt
Ayman Mokhtar Kamaly Department of Anesthesiology, Intensive Care Cairo Egypt
Ashraf Elsayed Elagamy Department of Anesthesiology, Intensive Care Cairo Egypt
Mohamed Saleh Ahmed Department of Anesthesiology, Intensive Care Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Principal Investigator Mohammed Ibrahim Elsayed Shahin Muhammadshahin1992@gmail.com +201024556447 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Resident of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data would be shared after deidentification. Study Protocol Beginning 1 months and ending 12 months following article publication. Investigators who provide a methodologically sound proposal. Proposals should be directed to corresponding author.
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