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.: PACTR201905558483142 Date of Approval: 13/05/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Phenylephrine for Prevention of Post-spinal Hypotension in CٍٍٍٍS
Official scientific title Phenylephrine for Prevention of Post-spinal Hypotension in Cesarean Section: a randomized controlled study
Brief summary describing the background and objectives of the trial Spinal anesthesia is commonly used for cesarean delivery because it avoids the risks of general anesthesia, However, spinal anesthesia is frequently associated with hypotension, which can have detrimental effects on the neonate. Studies over the last 2 decades had suggested that fetal acid-base status might be improved if α adrenergic agonists were used during cesarean delivery. The aim of this study was to demonstrate efficacy and the necessity of phenylephrine administration for prevention of post-spinal hypotension in cesarean section.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2018
Actual trial start date 01/03/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date 31/01/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group phenylephrine group a single bolus of phenylephrine 100 μg in 10ml normal saline a single bolus In the operating theatre, patient were positioned in the left lateral decubitus position and face oxygen mask 5 liters was applied and the head and neck were supported by a head ring, All patients were put on ASA standard monitoring, including 5 lead ECG, non-invasive blood pressure monitoring and pulse oximetry for oxygen saturation. Spinal Anesthesia was performed under complete aseptic conditions using 25 guage whitacre needle, at Lumber level 3-4. Hyperbaric levobupivacaine 0.5% (7.5 mg), and fentanyl 25 μg, were slowly injected over a period of 30 seconds after observing CSF flow. Immediately following spinal blockade, received a single bolus of phenylephrine 100 μg in 10ml normal saline 50
Control Group Saline Bolus single bolus of 10 ml normal saline single bolus In the operating theatre, patient were positioned in the left lateral decubitus position and face oxygen mask 5 liters was applied and the head and neck were supported by a head ring, All patients were put on ASA standard monitoring, including 5 lead ECG, non-invasive blood pressure monitoring and pulse oximetry for oxygen saturation. Spinal Anesthesia was performed under complete aseptic conditions using 25 guage whitacre needle, at Lumber level 3-4. Hyperbaric levobupivacaine 0.5% (7.5 mg), and fentanyl 25 μg, were slowly injected over a period of 30 seconds after observing CSF flow. Immediately following spinal blockade, received a single bolus of 10 ml normal saline 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA II patients full term single pregnancy undergoing elective cesarean section aged 20-35 height 160-170 cm emergency cesarean section any maternal or fetal comorbidity BMI >35 Adult: 19 Year-44 Year 20 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 04/02/2018 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 Incidence of post-spinal hypotension was used as a primary outcome 4 minutes after spinal anesthesia
Secondary Outcome Hemodynamic parameters: Systolic blood pressure, heart rate Baseline before spinal anesthesia, and at 2, 4, 6, 8, 10, 15, 20, 25, 30, 35, 40, 45 minutes after spinal anesthesia
Secondary Outcome neonatal Apgar score at 1, 5 minutes after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University, Ramses street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Abbasia, Cairo, Egypt Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Saleh Ahmed Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Mona R. Hosny Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Dalia M. Elfawy Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Hosny monamourmar@hotmail.com +201001540563 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt assistant professor of anesthesia
Role Name Email Phone Street address
Public Enquiries Moahmed 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 Moahmed 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
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