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.: PACTR202011750758363 Date of Approval: 30/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title hemodynamic effect of ondasterone in parturients undergoing cesarean section
Official scientific title Effect of prophylactic ondansetron for prevention of spinal induced hypotension and bradycardia in parturients undergoing elective cesarean delivery under spinal anesthesia, a randomized controlled trial
Brief summary describing the background and objectives of the trial Prevention of spinal induced hypotension is helpful to decrease the disaster effect of hypotension on the mother and the fetus as well as to avoid professionals stress on the surgical teams. However, there is no single method that completely prevents SIH during caesarian delivery and the best method is still controversial. Stimulation of BJR may be a cause of hypotension and blocking of this reflex can be one mechanism to reduce SIH. Ondansetron is postulated as blockage of BJR reflex so it could be one possible pharmacological alternative. the aim of this study is to assess the effect of prophylactic ondansetron in preventing spinal anesthesia-induced hypotension and bradycardia in pregnant mothers undergoing elective cesarean delivery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/12/2020
Actual trial start date
Anticipated date of last follow up 15/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants)
Recruitment status Not yet 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 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
Experimental Group ondasterone 10 mg 4 month The minimum standard monitoring like automated NIBP (model of monitoring apparatus Anyveiw A8), ECG, and pulse oximetry was used as a monitoring device. The 10 mg of ondansetron was diluted in 10 ml saline to decrease peripheral vein irritation by the responsible person. After a brief settling period, baseline hemodynamic measurements were recorded and Ondansetron was given 5 minutes before the spinal block. 56
Control Group saline 10 ml 4 month The minimum standard monitoring like automated NIBP (model of monitoring apparatus Anyveiw A8), ECG, and pulse oximetry was used as a monitoring device. After a brief settling period, baseline hemodynamic measurements were recorded and 10 ml saline was given 5 minutes before the spinal block. 56 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age between 18-35 years(67) ASA physical status class II • Hypersensitivity to ondansetron • History of Hypertensive disorders, anemia, Heart disease, diabetes, and placenta previa • Patient receiving selective serotonin reuptake inhibitor or migraine medication • Obesity (BMI ≥29-35 kg/m2) (69) • Height <155 cm(70) Adult: 19 Year-44 Year 18 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 20/12/2019 dilla university institutional review board
Ethics Committee Address
Street address City Postal code Country
dilla dilla 419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome hypotension and bradycardia every 3 minutes to 15 minutes and then every 10 minutes until skin closure.
Secondary Outcome side effects of ondasterone from spinal block to wearoff
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
dilla university referral hospital dilla dilla 419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
dilla university dilla dilla 419 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dilla university dilla dilla 419 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Semagne Mekonnen dilla dilla 419 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aynalem Befkadu aynalembbbefkadu@gmail.com +251916583316 dilla
City Postal code Country Position/Affiliation
dilla 419 Ethiopia lecturer
Role Name Email Phone Street address
Public Enquiries Derartu Neme dereneme.emma@gmail.com +251913386656 dilla
City Postal code Country Position/Affiliation
dilla 419 Ethiopia lecturer
Role Name Email Phone Street address
Scientific Enquiries Ayub Mohammed ayubmuh63@gmail.com +251912651363 dilla
City Postal code Country Position/Affiliation
dilla 419 Ethiopia lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participation data will be shared as required Statistical Analysis Plan,Study Protocol after 4 month by E-mail adress
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