Cairo University Hospitals
Cairo, Egypt
NCT Number: NCT07655245
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.
Trial opening soon.
Get Notified20 year–40 year
Female
Interventional
Not applicable
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia
Patient will receive placebo capsule
Time frame: After spinal anesthesia till delivery
The total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.
Time frame: After spinal anesthesia till end of delivery
Reduction of systolic blood pressure more than 20% of baseline
Time frame: After spinal anesthesia till delivery of the baby
Time to develop the first hypotensive episode in minutes
Time frame: at 10 minutes of delivery
Assessment of APGAR score of neonates
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Effect of Preoperative Oral Caffeine on Prophylactic Noradrenaline Requirement During Cesarean Delivery: A Double-blind Placebo-controlled Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT07534774
Spinal Hypotension
Boston, Massachusetts, United States
View Trial DetailsNCT07076654
Caffeine, Spinal Hypotension
Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT06822699
Hypoperfusion, Spinal Hypotension
Cairo, Giza Governorate, Egypt
View Trial DetailsNCT06825806
Doppler, Spinal Hypotension
Cairo, Giza Governorate, Egypt
View Trial Details