Menu
Not yet recruiting NCT07687355

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

No phase Interventional Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic Changes

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: Oxytocin bolus.
Who it may be relevant to
Registry conditions: Comparing 2 Techniques of iv Oxytocin Causing Hemodynamic Changes. Basic parameters: 18 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Drug Oxytocin bolus
    5IU OXYTOCIN diluted in 5ml normal saline, given as bolus over 5 second

Primary outcome measures

  • 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 [Time frame: Over period of giving the drug and after 2 to 5 mins of giving drug]

Eligibility criteria

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

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
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07687355 · ENJAY-PROP-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗