Caffeine and spinal anestheis related hypotension

Impact of Oral Caffeine Premedication on Maternal and Fetal OUtcomes in Elective Cesarean Delivery Under Spinal Anesthesia: A Randomized Clinical Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202101657899436

Enrollment

140

Registered

2021-01-15

Start date

2020-05-04

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Anaesthesia

Interventions

oral caffeine premedication

multivitamin placebo tablet

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: normotensive patients aged 18-45 years (ASA physical status I-II, BMI>18 and <35 Kg/m2 with full term uncomplicated singleton pregnancy scheduled for elective caesarean delivery under spinal anaesthesia

Exclusion criteria

Exclusion criteria: • Base line systolic blood pressure (SBP) less than 100 mmHg, • Pre-eclamptic patients, • Cardiac disease liver diseade kidney diseases. • Peptic ulcer disease or gastroesophageal reflux disease, • Severe anxiety • History of or any other neurological problem. • Allergy to amide local anesthetics or sensitivity to caffeine • Habitual coffee and other caffeinated beverages consumers. • Use of caffeine and other caffeine containing tablets or beverages or methyl xanthines within 2 days prior to the study. • Any contraindication of regional anesthesia, or patient refusal. • Suspicion of abnormal placentation. • Intrauterine growth restriction or fetal compromise

Design outcomes

Primary

Measure	Time frame
Incidence of hypotension (SAP<90 mmHg or <80% of base line whichever is greater) after spinal anesthesia until end of surgery).	—

Secondary

Measure	Time frame
Time to onset of first post spinal hypotension episode .;Magnitude, duration and number of hypotension episodes .;Number of rescue vasopressor boluses ;Vasopressor consumption ;Vasopressor consumption ;Neonatal APGAR score ;Umbilical cord blood gases and base excess . An arterial pH value under 7.20 will be considered as acidosis.;hemodynamic side effects reactive hypertension systolic blood pressure > 120% of baseline will be considered ;Bradycardia defined as a pulse rate of 100 bpm of baseline;intraoperative nausea, vomiting, dysrythmias	—

Measure

Time frame

Time to onset of first post spinal hypotension episode .;Magnitude, duration and number of hypotension episodes .;Number of rescue vasopressor boluses ;Vasopressor consumption ;Vasopressor consumption ;Neonatal APGAR score ;Umbilical cord blood gases and base excess . An arterial pH value under 7.20 will be considered as acidosis.;hemodynamic side effects reactive hypertension systolic blood pressure > 120% of baseline will be considered ;Bradycardia defined as a pulse rate of 100 bpm of baseline;intraoperative nausea, vomiting, dysrythmias

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Countries

Egypt

Contacts

Public Contactsabry abdallah

lacturer of anaesthesia and intensive care

sabryabdallah222@yahoo.com00201012378888

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026