Caffeine and Prophylactic Noradrenaline Requirement During Cesarean Delivery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Full-term singleton pregnant (>37 weeks)

ASA II

undergoing elective cesarean section.

Disqualifiers

Patient refusal

SBP < 100 mmHg

Allergy to local anesthetics or caffeine

Coagulopathy (INR>1.4 or platelets <75.000)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caffeine (200 mg)

    Drug

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

  • Placebo

    Drug

    Patient will receive placebo capsule

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: CaffeineActive comparator 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Incidence of spinal hypotension

Reduction of systolic blood pressure more than 20% of baseline

Time frame
After spinal anesthesia till end of delivery
2

Time to first hypotensive episode

Time to develop the first hypotensive episode in minutes

Time frame
After spinal anesthesia till delivery of the baby
3

APGAR score

Assessment of APGAR score of neonates

Time frame
at 10 minutes of delivery

Other outcomes

Sponsors and contacts

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