An interventional study of Caffeine (200 mg) and Placebo in Spinal Hypotension and Vasopressor, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Cairo University · Not applicable, Interventional, and Prevention
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.
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
30 minutes before spinal anesthesia in the preoperative area, the patient will receive 200 mg caffeine capsule
Drug: Caffeine (200 mg)
30 minutes before spinal anesthesia in the preoperative area, the patient will receive placebo
Drug: Placebo
Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia
Patient will receive placebo capsule
Average noradrenaline requirement
The total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.
Time frame: After spinal anesthesia till delivery
Incidence of spinal hypotension
Reduction of systolic blood pressure more than 20% of baseline
Time frame: After spinal anesthesia till end of delivery
Time to first hypotensive episode
Time to develop the first hypotensive episode in minutes
Time frame: After spinal anesthesia till delivery of the baby
APGAR score
Assessment of APGAR score of neonates
Time frame: at 10 minutes of delivery
Plan to share: Undecided — At present, we have not finalized a plan for sharing individual participant data. Decisions regarding data sharing will depend on factors such as ethical approval, participant consent, and institutional policies. If sharing becomes feasible, de-identified data may be made available upon reasonable request following appropriate review.
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Cairo University