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NCT Number: NCT07655245

Caffeine and Prophylactic Noradrenaline Requirement During Cesarean Delivery

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full-term singleton pregnant (>37 weeks)
  • ASA II
  • 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

Treatment and study plan

Caffeine (200 mg)

Drug

Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia

Placebo

Drug

Patient will receive placebo capsule

Primary outcomes

  1. Average noradrenaline requirement

    Time frame: After spinal anesthesia till delivery

    The total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.

Secondary outcomes

  1. Incidence of spinal hypotension

    Time frame: After spinal anesthesia till end of delivery

    Reduction of systolic blood pressure more than 20% of baseline

  2. Time to first hypotensive episode

    Time frame: After spinal anesthesia till delivery of the baby

    Time to develop the first hypotensive episode in minutes

  3. APGAR score

    Time frame: at 10 minutes of delivery

    Assessment of APGAR score of neonates

Study contacts

Contact information is provided by the study sponsor or research team.

Mina Adolf Helmy, MD

CONTACT

[email protected]

01275716942

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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