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.: PACTR201609001761694 Date of Registration: 02/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ondansetron for spinal hypotension prevention
Official scientific title Prevention of post-spinal hypotension in cesarean delivery using ondansetron: a randomized controlled trial
Brief summary describing the background and objectives of the trial Spinal block is the popular route for anesthesia for cesarean delivery. Maternal hypotension is a common complication in parturients undergoing cesarean delivery under spinal block.This randomized controlled double blinded trial will be conducted to evaluate the effect of preoperative ondansetron on the hemodynamic status of parturients receiving spinal anesthesia for CS.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cesarean sections,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2016
Actual trial start date 20/06/2016
Anticipated date of last follow up 20/08/2016
Actual Last follow-up date 25/08/2016
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
nil known N-34-2016
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 Patients will be randomly allocated using computer generated sequence Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group normal saline 10 ml once normal saline 50 Placebo
Experimental Group ondansetron 4 mg once anti emetic 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
lower segment cesarean sections patients with American society of anesthesiologists (ASA) I-II refusal to regional anesthesia obesity (BMI>30Kg/m2) twin pregnancies fetal malpresentations low baseline blood pressure (systolic blood pressure < 100 mmHg) cardiac co-morbidities (ASA) grading III and IV. 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 18/06/2016 faculty of medicine cairo university
Ethics Committee Address
Street address City Postal code Country
1 kasr alainy cairo 11223 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post spinal hypotension in cesarean delivery 1 minute after spinal block 3 minutes 6 minutes 9 minutes then every 5 minutes till end of operation
Secondary Outcome Hemodynamic variables (systolic blood pressure, diastolic blood pressure, and heart rate) 1 minute after the block 3 minutes after block 6 minutes after block 9 minutes after block then every 5 minutes till the end of operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine cairo university 1 kasr elainy cairo 11223 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anaesthesia department faculty of medicine cairo university 1 kasr alainy cairo 11223 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ibrahim Elsakka 6199 c Mokattam Cairo 11212 Egypt
Ahmed Mohamed Hasaneen 12 zahraa elmaadi Cairo 12123 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Elsakka ahmedsakka2@hotmail.com 00201002414221 6199c Mokattam
City Postal code Country Position/Affiliation
Cairo 11212 Egypt Lecturer of aneasthesia Faculty of medicine Cairo university
Role Name Email Phone Street address
Public Enquiries Ahmed Elsakka ahmedsakka2@hotmail.com 00201002414221 6199c Mokattam
City Postal code Country Position/Affiliation
Cairo 11212 Egypt Lecturer of aneasthesia Faculty of medicine Cairo university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elsakka ahmedsakka2@hotmail.com 00201002414221 6199c Mokattam
City Postal code Country Position/Affiliation
Cairo 11212 Egypt Lecturer of aneasthesia Faculty of medicine Cairo university
REPORTING
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