NCT07655245

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Sep 2026

First Submitted

Initial submission to the registry

June 12, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 16, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2026

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Spinal HypotensionVasopressor

Keywords

Spinal anesthesia induced hypotensionVasopressorCaffeine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Incidence of spinal hypotension

    After spinal anesthesia till end of delivery

  • Time to first hypotensive episode

    After spinal anesthesia till delivery of the baby

  • APGAR score

    at 10 minutes of delivery

Study Arms (2)

Caffeine

ACTIVE COMPARATOR

30 minutes before spinal anesthesia in the preoperative area, the patient will receive 200 mg caffeine capsule

Drug: Caffeine (200 mg)

Control

PLACEBO COMPARATOR

30 minutes before spinal anesthesia in the preoperative area, the patient will receive placebo

Drug: Placebo

Interventions

Caffeine (200 mg)DRUG

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

Caffeine
PlaceboDRUG

Patient will receive placebo capsule

Control

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Full-term singleton pregnant (\>37 weeks)
  • ASA II
  • undergoing elective cesarean section.

You may not qualify if:

  • Patient refusal
  • SBP \< 100 mmHg
  • Allergy to local anesthetics or caffeine
  • Coagulopathy (INR\>1.4 or platelets \<75.000)
  • Preeclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 41964042RESULT

  • 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.

    PMID: 40550198RESULT

  • 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.

    PMID: 41535923RESULT

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Mina Adolf Helmy, MD

CONTACT

01275716942minaadolf1988@cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

June 16, 2026

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

September 19, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Locations

EG(1)