Comparison of Two Different Doses of Phenylephrine on Oxytocin Hemodynamic Effect
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phenylephrine bolus 75 micrograms, Phenylephrine bolus 50 micrograms.
- Who it may be relevant to
- Registry conditions: Phenylephrine, Cesarean Birth. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Two Different Doses of Phenylephrine co Administration on Oxytocin- Induced Hemodynamic Effects
Overview
Cesarean section is one of the commonly performed surgical procedures in the world. Once baby is delivered during the surgical procedure anesthesiologist administer Oxytocin drug through IV cannula which helps the Uterus to contract so that excessive blood loss doesnt occur. But this is associated with fall in blood pressure frequently requiring administration of medications to treat low blood pressure. The most frequently used drug is phenylephrine which can administered along with oxytocin to prevent fall in blood pressure. This study will compare to different doses of Phenylephrine to prevent fall in blood pressure.
Detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide. Following delivery of the neonate, oxytocin is routinely administered intravenously to promote uterine contraction and thereby reduce the risk of postpartum hemorrhage. However, oxytocin administration is frequently associated with maternal hypotension, which may necessitate pharmacological intervention. Phenylephrine, a selective α-adrenergic agonist, is commonly used to prevent or treat oxytocin-induced hypotension due to its vasoconstrictive properties. The optimal prophylactic dose of phenylephrine administered concurrently with oxytocin remains uncertain. This study aims to compare two different doses of phenylephrine for the prevention of hypotension following oxytocin administration during cesarean section.
Interventions
- Drug Phenylephrine bolus 75 micrograms
After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 75 micrograms of Phenylephrine Intravenously. - Drug Phenylephrine bolus 50 micrograms
After delivery of Baby during C section, patient will be administered 3 IU of Oxytocin over 3 minutes along with 50 micrograms of Phenylephrine Intravenously.
Primary outcome measures
- Number of Hypotensive episodes [Time frame: Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine]
Secondary outcome measures (1)
- Rescue Phenylephrine consumed [Time frame: This will be the total amount of Phenylephrine consumed to treat the hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine]
Eligibility criteria
Inclusion criteria
\- Females having a singleton pregnancy Patients planned for elective cesarean section under spinal anesthesia
Exclusion criteria
- Patients having a placental abnormality
- Patients taking beta-blocker and vasodilator therapy
- Patients with hypertensive disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- Department of Anesthesia, Holy Family Hospital, Rawalpindi — Rawalpindi
Publications
- Sharma N, Agarwal S, Modi YC, Yadav A, Yadav J, Sindhi R, et al. Effect of Two Different Doses of Intravenous Phenylephrine on the Prevention of Oxytocin Induced Hypotension in Lower Segment Caesarean Section Under Subarachnoid Block: A Randomised Controlled Study. J Clin Diagn Res. 2023;17(9):16-21.
Identifiers
NCT: NCT07420127 · 781/IREF/RMU/2025