Vasopressor Infusion in Cesarean Delivery
Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
August 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2022
CompletedSeptember 27, 2021
September 1, 2021
4.5 years
August 10, 2017
September 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of post-spinal anesthesia hypotension
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
30 minutes after spinal anesthesia
Secondary Outcomes (7)
incidence of severe post-spinal anesthesia hypotension
30 minutes after spinal anesthesia
incidence of severe delivery hypotension
10 minutes after delivery
systolic blood pressure
2 hours after subarachnoid block
diastolic blood pressure
2 hours after subarachnoid block
heart rate
2 hours after subarachnoid block
- +2 more secondary outcomes
Study Arms (2)
Phenylephrine
ACTIVE COMPARATORWill receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
Norepinephrine
EXPERIMENTALWill receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
Interventions
Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.
Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg
Eligibility Criteria
You may qualify if:
- full term
- pregnant women
- scheduled for cesarean section
You may not qualify if:
- pre-ecpamsia
- eclampsia
- bleeding
- cardiac dysfuction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Mukhtar, Professor
Head of research committee section in anesthesia department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 14, 2017
Study Start
August 20, 2017
Primary Completion
March 1, 2022
Study Completion
March 10, 2022
Last Updated
September 27, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share