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Caffeine and Prophylactic Noradrenaline Requirement During Cesarean Delivery

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07655245
Enrollment
62
Registered
2026-06-17
Start date
2026-06-16
Completion date
2026-09-19
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Hypotension, Vasopressor

Keywords

Spinal anesthesia induced hypotension, Vasopressor, Caffeine

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.

Interventions

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

DRUGPlacebo

Patient will receive placebo capsule

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Average noradrenaline requirementAfter spinal anesthesia till deliveryThe total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.

Secondary

MeasureTime frameDescription
Incidence of spinal hypotensionAfter spinal anesthesia till end of deliveryReduction of systolic blood pressure more than 20% of baseline
Time to first hypotensive episodeAfter spinal anesthesia till delivery of the babyTime to develop the first hypotensive episode in minutes
APGAR scoreat 10 minutes of deliveryAssessment of APGAR score of neonates

Countries

Egypt

Contacts

CONTACTMina Adolf Helmy, MD
minaadolf1988@cu.edu.eg01275716942

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026