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.: PACTR201809811205627 Date of Approval: 11/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of pre-emptive intravenous ondansetron on patients presented to elective C.S under combined spinal-epidural anesthesia
Official scientific title The effect of pre-emptive intravenous ondansetron on patients presented to elective C.S under combined spinal-epidural anesthesia: a Randomized controlled study assessing hemodynamic parameters using cardiometry
Brief summary describing the background and objectives of the trial Combined spinal-epidural anesthesia (CSE) is often the anesthetic of choice for the elective CD. However, dramatic hemodynamic instability occurs frequently with spinal anesthesia which may be associated with adverse effects on the mother and newborn. The physiopathological mechanism involved in the occurrence of hypotension is systemic vascular resistance and central venous pressure from the sympathetic block with vasodilation. Bradycardia can occur from the shift in cardiac autonomic balance toward the parasympathetic system, from activation of left ventricular mechanoreceptors from a sudden decrease in left ventricular volume (Bezold-Jarisch reflex) (BJR). The main treatment is the vascular filling with crystalloid or starches and use of vasopressors. However, the study showed that it will be inefficient and found that no intervention reliably prevents hypotension during spinal anesthesia for cesarean section Ondansetron was shown to attenuate arterial blood pressure drop due to spinal anesthesia in general surgery population. Continuous measurement of CO provides the clinicians real-time data to determine if hypotension is mainly due to a reduction in blood volume or vasodilatation or pump issue. It, therefore, enables clinicians to optimize their management strategies. In this study, we aimed to evaluate the effect of pre-emptive intravenous ondansetron for prophylaxis of hypotension after CSE anesthesia in parturient scheduled for an elective cesarean. The incidence of hypotension will be the primary outcome, while our secondary outcomes will be the changes in the heart rate and the effect of the APGAR score.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/09/2018
Actual trial start date
Anticipated date of last follow up 07/03/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ondansetron group intravenously 4mg ondansetron in 10mL saline, 5 minutes once only received intravenously 4mg ondansetron in 10mL saline, 5 minutes before spinal puncture. 30
Control Group saline group 10mL of saline once only received 10mL of saline 5 minutes before spinal puncture 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 Patients presented for elective cesarean sections American Society of Anesthesiologists (ASA) patient status classification II ages 21-40 years 1. Age younger than 21 or older than 40 years 2. Major cardiovascular diseases 3. Preexisting hypertension or gestational hypertension, preeclampsia 4. Body mass index greater than 35 kg/m2. 5. Emesis gravidarum 6. Contraindication to neuraxial anesthesia (patient refusal, unstable hemodynamic, and coagulation abnormalities) 7. Any study drugs allergy. 8. emergent cesarean sections, multiple parities (twins/triplets) 9. > 1,000 ml blood loss, Adult: 19 Year-44 Year 21 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 29/08/2018 research ethics committee
Ethics Committee Address
Street address City Postal code Country
1, El-Geish st, Tanta,Al-Gharbia Governate, Egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence of hypotension will be collected at pre-defined time points: baseline measurement while supine (T0), in the sitting position (T1), immediately after injection of spinal anesthesia (T2), 5 and 10 min after spinal anesthesia while supine (T3, T4), at skin incision (T5), 3 min after skin incision (T6), at newborn delivery (T7), 3 min after delivery (T8), 10 min after delivery (T9) and at the end of surgery (T10). baseline measurement while supine and nine time after
Secondary Outcome changes in the heart rate will be collected at pre-defined time points: baseline measurement while supine (T0), in the sitting position (T1), immediately after injection of spinal anesthesia (T2), 5 and 10 min after spinal anesthesia while supine (T3, T4), at skin incision (T5), 3 min after skin incision (T6), at newborn delivery (T7), 3 min after delivery (T8), 10 min after delivery (T9) and at the end of surgery (T10). and the effect of the APGAR score. baseline measurement while supine and nine time after. APGAR score at 5, and 10minutes.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university 1, El-Geish st, Tanta,Al-Gharbia Governate, Egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sameh El-Fate Tanta Qism 2, Gharbia Governorate Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany omara amanyfaheem2011@yahoo.com +02201008372249 Stadium Rd, Tanta Qism 2, Gharbia Governorate
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecture
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com +02201008372249 moheb SabekanTanta Qism 2, Gharbia Governorate
City Postal code Country Position/Affiliation
tanta 31527 Egypt professor
Role Name Email Phone Street address
Public Enquiries nada Omara Dr.nada.emera@gmail.com +02201008372249 Stadium Rd Tanta Qism 2, Gharbia Governorate
City Postal code Country Position/Affiliation
tanta 31527 Egypt assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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