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Clinical Trials/NCT07655245
NCT07655245Not yet recruitingNot Applicable

Effect of Preoperative Oral Caffeine on Prophylactic Noradrenaline Requirement During Cesarean Delivery: A Double-blind Placebo-controlled Trial

Cairo University1 site in 1 country62 target enrollmentStarted: June 16, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
62
Locations
1

Study Overview

Brief Summary

Spinal anesthesia is the preferred regional technique in obstetric practice because it provides high maternal satisfaction and eliminates the need for airway manipulation. Despite these advantages, it is frequently complicated by spinal anesthesia-induced hypotension , defined as a reduction in systolic blood pressure of more than 20% from baseline or an absolute SBP below 100 mmHg. Spinal hypotension can have serious consequences, including maternal hypoperfusion that may lead to neurological or renal dysfunction, as well as fetal acidosis and bradycardia, which can compromise neonatal outcomes. The present study aims to evaluate the effect of preoperative caffeine administration on noradrenaline requirements during spinal anesthesia in obstetric patients. Specifically, the objectives are to compare noradrenaline requirements between the study groups and to assess the incidence of hypotension in both groups.

Detailed Description

Spinal anesthesia is considered the technique of choice in obstetric practice because it provides excellent maternal comfort and avoids the risks associated with airway manipulation during general anesthesia. Nevertheless, its use is often complicated by a significant drop in blood pressure, which can reduce blood flow to vital organs and impair maternal brain and kidney function. More importantly, decreased uteroplacental perfusion may compromise fetal oxygenation, leading to acidosis and slowing of the heart rate, both of which can negatively affect neonatal outcomes. These risks make it essential to explore preventive strategies that can stabilize blood pressure during spinal anesthesia. Caffeine, a widely available and inexpensive stimulant, enhances sympathetic nervous system activity and may counteract the vasodilation that contributes to low blood pressure. This study therefore investigates whether giving caffeine before anesthesia can reduce the need for noradrenaline, a commonly used vasopressor, and whether it can lower the incidence of hypotension. By examining these outcomes, the research aims to determine if caffeine could serve as a simple intervention to improve both maternal safety and neonatal wellbeing.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Full-term singleton pregnant (>37 weeks)
  • undergoing elective cesarean section.

Exclusion Criteria

  • Patient refusal
  • SBP < 100 mmHg
  • Allergy to local anesthetics or caffeine
  • Coagulopathy (INR>1.4 or platelets <75.000)
  • Preeclampsia

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mina Adolf Helmy

Doctor

Cairo University

Study Sites (1)

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