Comparison of Two Different Doses of Phenylephrine on Oxytocin Hemodynamic Effect

Effects of Two Different Doses of Phenylephrine co Administration on Oxytocin- Induced Hemodynamic Effects

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.

Study Overview

• Status: Recruiting
• Conditions: Phenylephrine; Cesarean Birth
• Intervention / Treatment: Drug: Phenylephrine bolus 75 micrograms; Drug: Phenylephrine bolus 50 micrograms

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Farwa Javed Principal Investigator, MBBS; Phone Number: +92 304 8954091; Email: farwajaved44@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • Recruiting
      • Department of Anesthesia, Holy Family Hospital, Rawalpindi
      • Contact: Jawad Head of Department of Anesthesia, MBBS, FCPS; Phone Number: +92 333 5428866; Email: drjayzee@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phenylephrine 75	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.
Active Comparator: Phenylephrine 50	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hypotensive episodes	Hypotension will be defined as fall in Mean Arterial pressure by more than 20% from baseline value.	Number of hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine

Secondary Outcome Measures

Outcome Measure	Time Frame
Rescue Phenylephrine consumed	This will be the total amount of Phenylephrine consumed to treat the hypotensive episodes occuring upto 10 minutes after administration of Oxytocin and Phenylephrine

Collaborators and Investigators

• Sponsor: Rawalpindi Medical College
• Investigators: Study Chair: Jawad Zahir, Head of Department of Anesthesia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Phenylephrine; Oxytocin induced hypotension
• Other Study ID Numbers: 781/IREF/RMU/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not allowed by Hospital Ethical Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes