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.: PACTR202302481261045 Date of Approval: 03/02/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of intravenous fluid and ephedrine as a prophylaxis in the prevention of spinal anesthesia induced hypotension among delivering mothers.
Official scientific title Comparison of crystalloid preloading versus ephedrine prophylaxis to prevent spinal anesthesia induced hypotension during cesarean delivery: a randomized clinical trial
Brief summary describing the background and objectives of the trial Hypotension in patients who take spinal anesthesia is a potentially serious issue. Expansion of the intravascular volume can be achieved by preloading with crystalloid fluids, which is a common practice in elective cases. Ephedrine, as a prophylaxis, has been recently practiced to prevent such occurrence. The study was conducted to compare the effect between preloading with crystalloid fluids and administering ephedrine as a prophylaxis to prevent spinal anesthesia-induced hypotension among mothers undergoing elective C-section delivery. A randomized clinical trial was conducted and all mothers who underwent elective cesarean delivery within the study period were included through random allocation of participants into two comparable groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/12/2021
Actual trial start date 01/12/2021
Anticipated date of last follow up 01/02/2022
Actual Last follow-up date 01/02/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ephedrine Group Participants were started on ephedrine prophylaxis; initially 5mg was given 1 minute after the spinal injection. Another 5mg was given again 1 minute later. Then, the patient received 1mg of ephedrine every 1 min until the 15th minute. 15 minutes of followup Patients initially were encountered during the preoperative assessment period. Informed written consent was obtained. A thorough pre-anesthetic evaluation was done. Previous anesthetic exposure and drug sensitivity were enquired. Routine preoperative laboratory investigations were conducted. No premedication was given. Patients were kept fasting for the night of 8 hours. In the preparation room, an intravenous 18G cannula was inserted. Upon arrival to the operating room, patients were attached to vital sign monitoring instruments and continuous monitoring was carried out with noninvasive blood pressure evaluation and pulse oximetry and baseline vital signs were recorded before the start of the procedure. During the intraoperative period, the intravenous line was secured with a lactated Ringer’s solution for all mothers. During spinal injection, patients were made in sitting position, spinal puncture was performed under aseptic precautions with a G25 Fr at the L3/4 or L4/5 interspace, and 2 ml of 5% hyperbaric bupivacaine was administered. Patients were made in a supine position immediately after spinal injection. Patients were followed for block progression and the level of the block was recorded. Participants were started on ephedrine prophylaxis; initially 5mg was given 1 minute after the spinal injection. Another 5mg was given again 1 minute later. Then, the patient received 1mg of ephedrine every 1 min until the 15th minute. Concurrently, the mentioned vital signs were recorded immediately in with 5 mg bolus IV ephedrine. Occurrences of nausea and vomiting were also recorded. Patients in both groups received 10 IU oxytocin (5 IU intravenously and 5 IU in 500 ml of the running ringer lactated solution). 30
Control Group Preloading Group Participants in this group received 1 liter of normal saline 15 minutes before spinal injection as a preload. 15 minutes before spinal injection Patients initially were encountered during the preoperative assessment period. Informed written consent was obtained. A thorough pre-anesthetic evaluation was done. Previous anesthetic exposure and drug sensitivity were enquired. Routine preoperative laboratory investigations were conducted. No premedication was given. Patients were kept fasting for the night of 8 hours. In the preparation room, an intravenous 18G cannula was inserted. Upon arrival to the operating room, patients were attached to vital sign monitoring instruments and continuous monitoring was carried out with noninvasive blood pressure evaluation and pulse oximetry and baseline vital signs were recorded before the start of the procedure. Participants in this group received 1 liter of normal saline 15 minutes before spinal injection as a preload. During the intraoperative period, the intravenous line was secured with a lactated Ringer’s solution for all mothers. During spinal injection, patients were made in sitting position, spinal puncture was performed under aseptic precautions with a G25 Fr at the L3/4 or L4/5 interspace, and 2 ml of 5% hyperbaric bupivacaine was administered. Patients were made in a supine position immediately after spinal injection. Patients were followed for block progression and the level of the block was recorded. Concurrently, the vital signs were recorded immediately in with 5 mg bolus IV ephedrine. Occurrences of nausea and vomiting were also recorded. Patients in received 10 IU oxytocin (5 IU intravenously and 5 IU in 500 ml of the running ringer lactated solution). 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Mothers with physical status of ASA I and II Those with full term of a single pregnancy Mothers with the age range of 18 to 40 years Mothers who didn’t consent to participate in the study Those who were not fit for spinal anesthesia Those with a history of allergic reactions to local anesthetics Those with preceding or pregnancy-induced hypertension Patients with coagulopathy of any cause Patients with severe cardiac, respiratory, hepatic or renal diseases Preeclamptic and ecpamptic patients Those who developed emergency conditions during the intraoperative period Adult: 19 Year-44 Year 18 Year(s) 40 Year(s) Both
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 21/01/2022 Research Ethical Clearance Committee
Ethics Committee Address
Street address City Postal code Country
wakiro street Asmara 0000 Eritrea
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood pressure of every patient in both groups was recorded every three minutes and the mean value for every record as well as the overall perioperative mean systolic blood pressure was computed. The baseline systolic blood pressure of the two study groups was comparable with no significant difference at both bivariate and multivariate levels. After the administration of spinal anesthesia, monitoring blood pressure was continued and significant differences were observed in the measures of systolic blood pressure and it was higher in the ephedrine group in the 7th (p<0.05), 10th (p<0.05), 13th (p<0.05), 16th (p<0.001), 19th (p<0.0001), 22nd (p<0.0001), 25th (p<0.001) minutes. Analysis at multivariable level showed significant difference at 16th (p=0.002), 19th (p<0.0001), 22nd (p=0.001) minutes. Meanwhile, the overall perioperative mean systolic blood pressure was also highly significant (p=0.004) at multivariable level (Table 2). Regarding the score of pulse rate, the baseline was similarly comparable with non-significant difference (p>0.05) at all times (Table 3). Vital signs were recorded immediately in the first minute after spinal injection and then every three minutes in the prepared checklist until the surgery was finished.
Secondary Outcome The secondary outcomes can be explained by the secondary effect of the the provided interventions. Besides the primary outcome, they also have a secondary outcome on the patient conditions such as nausea and vomiting. The incidences of nausea and vomiting were highly significant both clinically and statistically in the preloading group. 3.3% of the patients in the ephedrine group experienced hypotension requiring rescue dose of ephedrine. Time at which secondary outcome was measured is similar to that of primary outcome.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orotta National Referral Maternity Hospital Asmara Asmara Eritrea
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Seharti street Asmara 0000 Eritrea
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Orotta College of Medicine and Health Sciences Seharti Street Asmara 0000 Eritrea University
Primary Sponsor Ministry of Health Research policy and HRD department Wakiro Street Asmara 0000 Eritrea Governmental Sector
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yonatan Andemeskel yonimer2@gmail.com 002917138237 121, Naval Base
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea Prinicipal investigator
Role Name Email Phone Street address
Public Enquiries Michael Mengistu Mikoberaki88@gmail.com 002917305987 Arbaete Asmara Street
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea College lecturer and research coordinator
Role Name Email Phone Street address
Scientific Enquiries Betiel Kidanemariam Betielyk@gmail.com 002917422105 Gedjeret street
City Postal code Country Position/Affiliation
Asmara 0000 Eritrea College lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after deidentification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. o Anyone who wishes to access the data o Data will be available for any purpose and indefinitely
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 06/01/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 06/01/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information