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.: PACTR202301602396344 Date of Approval: 09/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title intravenous phenylephrine versus intravenous ondansterone in prevention of hypotension
Official scientific title The efficacy of intravenous phenylephrine versus intravenous ondansterone in prevention of hypotension in women undergoing cesarean section under spinal anesthesia; a comparative study.
Brief summary describing the background and objectives of the trial Multiple methods have been proposed to prevent the incidence of hypotension in women undergoing cesarean section under spinal anesthesia. This study was conducted to compare between the efficacy of phenylephrine (50 μg/min) versus ondansetron (8 mg) in the prevention of such complication.
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 Prevention
Anticipated trial start date 20/12/2022
Actual trial start date 21/12/2022
Anticipated date of last follow up 20/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 182
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group phenylepherine group Group P will include 91 cases who will be commenced on phenylephrine infusion (50 μg/min given after puncture). till end of surgery The patient will be positioned in the sitting position, and after that, spinal anesthesia will be performed at L 3 – 4 or L 4 – 5 levels by a 27-gauge Quincke needle. Hyperbaric bupivacaine (0.5%) along with fentanyl (25-μg) were intrathecally administered. Then, the patient will be placed in the supine position, and fluid infusion will be started. Sensory blockade will be tested by an alcohol swab whereas motor block will be evaluated using the Bromage scale.spinal anathesia followed by continues infusion of phenylepherine 91 Active-Treatment of Control Group
Experimental Group ondansterone group which will include the other 91 cases who will be administered ondansetron (8 mg given 5 minutes before puncture). till end of surgery 91 cases who will be administered ondansetron (8 mg given 5 minutes before puncture of spinal anathesia) 91
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age between 20 and 45 years and prepared for elective caesarian section. • American Society of anesthesiologists (ASA) I or II. • Age beyond the previously mentioned limits. • Obesity • ASA > II. • Having contraindications for the study medications. • Complicated pregnancy and emergency caesarian section. 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 22/11/2022 mansoura university IRB
Ethics Committee Address
Street address City Postal code Country
IRB office-ground floor-building A - faculty of medicine-mansoura university mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparison of mean arterial blood pressure in the studied group. basal 1,3,5,7,11,13,15,20,25,30min after spinal anesthesia.
Secondary Outcome post-operative complications , ephedrine use in the two studied groups. detect complication if present, percent of ephedrine injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital gomhoreia street , mansoura , egypt mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohammed nashaat talkha ,mansoura mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university talkha , mansoura mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed nashaat moh_nashaat@mans.edu.eg 01092323198 talkha, mansoura, egypt
City Postal code Country Position/Affiliation
mansoura 35511 Ecuador corresponding author
Role Name Email Phone Street address
Scientific Enquiries ali rashad alydawood441@yahoo.com 01092323198 gomhoria street , mansoura
City Postal code Country Position/Affiliation
mmansoura Egypt coauthor
Role Name Email Phone Street address
Public Enquiries mohammed nashaat moh_nashaat@mans.edu.eg 01092323198 talkha
City Postal code Country Position/Affiliation
mansoura Egypt main author
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication open access
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