Compare Hemodynamic Effect of Oxytocin Bolus and Infusion During Cesarean Section Under Spinal Anesthesia

STUDY OF EFFECT OF HEMODYNAMIC CHANGES CAUSED BY OXYTOCIN DURING CESAREAN SECTION UNDER SPINAL ANESTHESIA: COMPARISON BETWEEN INTRAVENOUS BOLUS AND INFUSION TECHNIQUE

Oxytocin is routinely used during a cesarean section to promote uterine contraction and prevent postpartum hemorrhage. It is typically administered immediately after delivery of the baby, either as a slow intravenous bolus followed by a continuous infusion or as an infusion alone, depending on clinical protocols. By stimulating the uterine muscles to contract, oxytocin helps reduce blood loss and facilitates uterine involution. Care is taken to avoid rapid high-dose administration, as this may lead to side effects such as hypotension and tachycardia

Study Overview

• Status: Not yet recruiting
• Conditions: Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic Changes
• Intervention / Treatment: Drug: Oxytocin bolus

Detailed Description

The administration of Oxytocin during cesarean section under Spinal anesthesia is associated with significant hemodynamic changes, and these effects differ depending on whether the drug is given as an intravenous bolus or as a controlled infusion. Oxytocin causes vasodilation and decreases systemic vascular resistance, which can lead to hypotension, reflex tachycardia, and occasionally nausea or flushing-effects that are often exaggerated under spinal anesthesia due to pre-existing sympathetic blockade. When given as a rapid IV bolus (e.g., 5-10 IU), there is a sudden drop in blood pressure and a marked increase in heart rate, sometimes accompanied by transient myocardial ischemia in susceptible patients. In contrast, administering oxytocin as a slow infusion (e.g., 10-40 IU diluted in IV fluids over time) results in more gradual hemodynamic changes, with better stability of blood pressure and heart rate. Comparative studies have consistently shown that infusion regimens are associated with fewer adverse cardiovascular effects while still providing adequate uterine contraction. Therefore, current clinical practice favors low-dose slow bolus followed by infusion, or infusion alone, to minimize hemodynamic instability while effectively preventing postpartum hemorrhage.

• Study Type: Interventional
• Enrollment (Estimated): 262
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Navishta Sahar Arif Trainee medical officer, MBBS; Phone Number: +92 +923333493330; Email: lailo_dr@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Women within age range 18-40 Years Women undergoing caesarian with oxytocin under spinal anesthesia as defined in the operational definition.

Exclusion Criteria Women with placenta praevia Women with ruptured membranes Women with hypertensive disorders or diabetes mellitus Women on immunosuppressant

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin bolus group; Patient recieving oxytocin bolus I/v during Cesarean section under spinal anesthesia	Drug: Oxytocin bolus; 5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second
Active Comparator: Oxytocin infusion group; Oxytocin iv transfusion during Cesarean section	Drug: Oxytocin bolus; 5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate and blood pressure changes in beats per minute and mmHg respectively by comparing intravenous bolus and infusion oxytocin during Cesarean section under spinal anesthesia	Comparison of iv bolus and infusion technique of oxytocin causing changes hemodynamic are noticed while it is given to patient undergoing Cesarean section under spinal anesthesia	Over period of giving the drug and after 2 to 5 mins of giving drug

Collaborators and Investigators

• Sponsor: Hayatabad Medical Complex
• Investigators: Principal Investigator: Dr Navishta Sahar Arif, Trainee medical officer, MBBS, PGMI/ Hayatabad medical complex, peshawar

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Oxytocin bolus; Oxytocin nfusion technique; Blood pressure changes by oxytocin; Oxytocin in cesarean section
• Other Study ID Numbers: ENJAY-PROP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient confidentiality and institutional policies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No