NCT07076654

Brief Summary

Hypotension after spinal anesthesia is critical. Thus several interventions have been proposed to mitigate such effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2025

Completed
Last Updated

December 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 1, 2025

Last Update Submit

December 10, 2025

Conditions

CaffeineSpinal Hypotension

Keywords

Spinal hypotensionCaffeineCesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Incidence of spinal hypotension

    Decrease systolic blood pressure \< 20% of baseline value

    After spinal anesthesia till delivery

Secondary Outcomes (4)

  • Time to first hypotensive episode

    after induction of spinal anesthesia

  • Incidence of severe hypotension

    After onset of spinal anesthesia

  • APGAR score

    at 5 minutes after delivery

  • Umbilical artery pH

    At 5 minutes after delivery

Study Arms (2)

Caffeine

ACTIVE COMPARATOR

Patients will receive oral caffeine 200 mg before spinal anesthesia

Drug: Caffeine (200 mg)

Control group

PLACEBO COMPARATOR

Will receive placebo before spinal anesthesia

Drug: Placebo

Interventions

PlaceboDRUG

Patient at this arm will receive placebo

Control group
Caffeine (200 mg)DRUG

Oral caffeine will be given as 200 mg before spinal anesthesia

Caffeine

Eligibility Criteria

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

You may qualify if:

  • full term pregnant
  • undergoing elective cesarean delivery

You may not qualify if:

  • patient refusal
  • baseline systolic pressure \< 100 mmHg
  • contraindication to spinal anesthesia
  • allergy to caffeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 6890, Egypt

Location

Related Publications (6)

  • Grosso G, Godos J, Galvano F, Giovannucci EL. Coffee, Caffeine, and Health Outcomes: An Umbrella Review. Annu Rev Nutr. 2017 Aug 21;37:131-156. doi: 10.1146/annurev-nutr-071816-064941.

    PMID: 28826374RESULT

  • Antar SS, Metaweh A, Neamatallah H, Abdelfattah M, Abdelbaser I, Awad KA. Preoperative oral caffeine as prophylaxis against post-spinal hypotension in patients undergoing orthopedic lower limb surgery: A randomized, placebo-controlled, double-blinded study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101537. doi: 10.1016/j.accpm.2025.101537. Epub 2025 May 1.

    PMID: 40318850RESULT

  • 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

  • Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.

    PMID: 39848332RESULT

  • Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

    PMID: 29090733RESULT

  • 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: 41535923DERIVED

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical care

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 22, 2025

Study Start

July 12, 2025

Primary Completion

October 1, 2025

Study Completion

October 2, 2025

Last Updated

December 18, 2025

Record last verified: 2025-07

Locations

EG(1)