Comparison of Two Different Doses of Phenylephrine on Oxytocin Hemodynamic Effect

NCT07420127 | Recruiting Phase 4 DMC

• 1 other identifier: 781/IREF/RMU/2025
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phenylephrine; Cesarean Birth

Keywords

Phenylephrine; Oxytocin induced hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Phenylephrine 75

ACTIVE COMPARATOR

Drug: Phenylephrine bolus 75 micrograms

Phenylephrine 50

ACTIVE COMPARATOR

Drug: Phenylephrine bolus 50 micrograms

Interventions

Phenylephrine bolus 75 micrograms DRUG

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.

Phenylephrine 75

Phenylephrine bolus 50 micrograms DRUG

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.

Phenylephrine 50

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Females having a singleton pregnancy Patients planned for elective cesarean section under spinal anesthesia

You may not qualify if:

• Patients having a placental abnormality
• Patients taking beta-blocker and vasodilator therapy
• Patients with hypertensive disorder

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Department of Anesthesia, Holy Family Hospital, Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

Study Officials

• Jawad Zahir

  Head of Department of Anesthesia

  STUDY CHAIR

Central Study Contacts

Farwa Javed Principal Investigator, MBBS

CONTACT

+92 304 8954091; farwajaved44@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)