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.: PACTR202303595933891 Date of Approval: 08/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Optimal time for early diagnosis and management of hypotension in patients undergone lower segment cesarean section with spinal anesthesia
Official scientific title Optimal time for early diagnosis and management of hypotension in patients undergone lower segment cesarean section with spinal anesthesia
Brief summary describing the background and objectives of the trial This study will aim to detect optimal time for early diagnosis and management of hypotension in patients who will undergo cesarean section with spinal anesthesia.Eighty patients will be allocated in this study, ASA I or II and singleton pregnancy beyond 36 weeks of gestation will be scheduled for elective C.S under spinal anesthesia. The patients will be fasted before surgery. Electrocardiograph (ECG), oxygen saturation (SpO2), baseline blood pressure (systolic & diastolic & mean) and heart rate (HR) will be established after the patients entered the operating room.In group (I) blood pressure (BP) will be monitored by the CNAP system which consists of a double-finger sensor, a pressure transducer mounted on the forearm, and an upper arm cuff for calibration.The cuff will be placed over the right arm. A pair of inflatable finger cuffs will be placed on the index finger and middle finger of the right hand. In the NIAP groups, an oscillometric non-invasive BP cuff will be placed over the right arm of the patients. Baseline BP will be defined as the mean of three consecutive readings recorded at 1-min intervals after being at rest for 3 min. All the patients will be subjected to the following: 1- Demographic data (age, sex, BMI and duration of surgery). 2- Base line blood pressure (Systolic &Diastolic &Mean) and heart rate before induction of spinal anesthesia will be recorded. 3- The time from intrathecal administration till delivery of fetus will be recorded. 4- A continuous monitoring of blood pressure and heart rate will be performed in group I and changes in blood pressure and heart rate will be monitored every 2,3,5 min in II,III,IV groups respectively. 5- The blood pressure will be measured immediately when symptoms of hypotension, including nausea, dizziness, vomiting and dyspnea occur. 6- The time of administering dose of ephedrine will be recorded in four groups. 7- The attending neonatologist will assess Apgar scores at 1 and 5 min after delivery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 11/12/2022
Actual trial start date 18/12/2022
Anticipated date of last follow up 18/06/2023
Actual Last follow-up date 18/06/2023
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status 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 Group I parturient were hemodynamically monitored using Continuous Non invasive Arterial Pressure monitoring (CNAP). continuous monitoring till end of procedure parturient were hemodynamically monitored using Continuous Non invasive Arterial Pressure monitoring (CNAP). 20
Control Group Group II parturient were hemodynamically monitored using Non Invasive Arterial Pressure monitoring (NIAP) every2 min. Every 2 minutes till end of procedure parturient were hemodynamically monitored using Non Invasive Arterial Pressure monitoring (NIAP) every2 min. 20 Dose Comparison
Experimental Group Group III parturient were hemodynamically monitored using non Invasive Arterial Pressure monitoring (NIAP) every 3 min Every 3 minutes till end of procedure parturient were hemodynamically monitored using non Invasive Arterial Pressure monitoring (NIAP) every 3 min 20
Experimental Group Group IV parturient were hemodynamically monitored using non Invasive Arterial Pressure monitoring (NIAP) every 5 min Every 5 minutes till end of procedure parturient were hemodynamically monitored using non Invasive Arterial Pressure monitoring (NIAP) every 5 min 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-ASA I or II 2- parturient 3-beyond 36 weeks of gestation 4- elective C.S under spinal anesthesia. 1- Patients with history of any cardiac diseases as cardiomyopathy & hypertension & arrhythmia, 2- cerebrovascular, vascular pathology of the upper limbs as vascular stenosis or Raynaud's diseases, 3- respiratory, hepatic, renal, endocrinal disease, 4- preeclampsia, placenta previa, fetal distress or developmental malformation, 5- history of allergy to study medication Adult: 19 Year-44 Year 20 Year(s) 45 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 11/12/2022 Kafrelsheikh university faculty of medicine Scientific research ethics committee
Ethics Committee Address
Street address City Postal code Country
El Geish street, Kafrelsheikh Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The first time of occurrence of hypotension. during the whole procedure
Secondary Outcome 1-The changes in blood pressure categories. 2-Neonatal Apgar score 3-Adverse effects of spinal anesthesia. during the whole procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospital El-Geish street Kafrelsheikh Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Kamal hafez Arafa 12 Tout Angh Amoun street Tanta 3351111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sherif Kamal Hafez Arafa 12 Tout Engh Amoun street Tanta 3351111 Egypt Individual
Secondary Sponsor Amir Abouzkry Elsayed Elmontazah - Kafrelsheikh Kafrelsheikh 33511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Arafa sherifhafez1980@gmail.com 00201005714014 12 Tout Angh Amoun Street
City Postal code Country Position/Affiliation
Tanta 3351111 Egypt Assistant professor of Anesthesia and Surgical ICU Faculty of Medicine Kafrelsheikh University
Role Name Email Phone Street address
Public Enquiries Sherif Arafa sherifhafez1980@gmail.com 00201005714014 12 Tout Angh Amoun street
City Postal code Country Position/Affiliation
Tanta 3351111 Egypt Assistant professor of Anesthesia and Surgical ICU Faculty of Medicine Kafrelsheikh University
Role Name Email Phone Street address
Scientific Enquiries Amir Elsayed aabouzkry@gmail.com 00201016326544 Elmontazah Kafrelsheikh
City Postal code Country Position/Affiliation
Kafrelsheikh 33511 Egypt Assistant professor of Anesthesia and Surgical ICU Faculty of Medicine Kafrelsheikh University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in article, after de identification (text,tables ,figure and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
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