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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vasopressor; Spinal Hypotension
• Intervention / Treatment: Drug: Caffeine (200 mg); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mina Adolf Helmy, MD; Phone Number: 01275716942; Email: minaadolf1988@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospitals
    • Contact: Mina Adolf Helmy, MD; Phone Number: 01275716942; Email: minaadolf1988@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caffeine; 30 minutes before spinal anesthesia in the preoperative area, the patient will receive 200 mg caffeine capsule	Drug: Caffeine (200 mg); Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia
Placebo Comparator: Control; 30 minutes before spinal anesthesia in the preoperative area, the patient will receive placebo	Drug: Placebo; Patient will receive placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average noradrenaline requirement	The total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.	After spinal anesthesia till delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of spinal hypotension	Reduction of systolic blood pressure more than 20% of baseline	After spinal anesthesia till end of delivery
Time to first hypotensive episode	Time to develop the first hypotensive episode in minutes	After spinal anesthesia till delivery of the baby
APGAR score	Assessment of APGAR score of neonates	at 10 minutes of delivery

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Helmy MA, Helmy KA, Kaddah RA, Shamma MA, Ali MA, Milad LM. Femoral artery Doppler as a novel predictor of spinal hypotension in elective cesarean delivery cases: a prospective observational study. Int J Obstet Anesth. 2025 Aug;63:104706. doi: 10.1016/j.ijoa.2025.104706. Epub 2025 Jun 18.
• Helmy MA, Helmy KA, Darandly WME, Awad HH, Morsy F, Kaddah RA, Shamma MA, Milad LM. Prediction of spinal anesthesia-induced hypotension during cesarean delivery: a narrative review. J Anesth Analg Crit Care. 2026 Apr 11;6(1):61. doi: 10.1186/s44158-026-00382-y.
• Helmy MA, Helmy KA, Zaki RM, Khatab SA, Embaby SA, Kaddah RA, Shamma MA, Milad LM. Caffeine before cesarean delivery: a novel preventive strategy against spinal hypotension, a double blind placebo-controlled trial. J Anesth Analg Crit Care. 2026 Jan 15;6(1):12. doi: 10.1186/s44158-025-00333-z.

Study record dates

Study Major Dates

• Study Start (Estimated): June 16, 2026
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 19, 2026

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Caffeine; Vasopressor; Spinal anesthesia induced hypotension
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkaloids; Purinones; Purines; Xanthines; Caffeine
• Other Study ID Numbers: Caffeine and noradrenaline

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No