Oral Caffeine and Spinal-Induced Hypotension

December 10, 2025 updated by: Mina Adolf Helmy, Cairo University

Effectiveness of Preoperative Oral Caffeine in Preventing Spinal-Induced Hypotension During Cesarean Delivery: A Double Blind Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypotension is a critical issue related to spinal anesthesia during cesarean delivery. Researchers of this study aimed to evaluate the impact of preoperative oral caffeine on the incidence of spinal hypotension during cesarean delivery.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 6890
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • full term pregnant
  • undergoing elective cesarean delivery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caffeine
Patients will receive oral caffeine 200 mg before spinal anesthesia
Drug: Caffeine (200 mg)
Oral caffeine will be given as 200 mg before spinal anesthesia
Placebo Comparator: Control group
Will receive placebo before spinal anesthesia
Drug: Placebo
Patient at this arm will receive placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of spinal hypotension
Time Frame: After spinal anesthesia till delivery
Decrease systolic blood pressure < 20% of baseline value
After spinal anesthesia till delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first hypotensive episode
Time Frame: after induction of spinal anesthesia
time to incidence of hypotension
after induction of spinal anesthesia
Incidence of severe hypotension
Time Frame: After onset of spinal anesthesia
reduced systolic pressure < 60% of baseline value
After onset of spinal anesthesia
APGAR score
Time Frame: at 5 minutes after delivery
APGAR score calculation at 5 minutes
at 5 minutes after delivery
Umbilical artery pH
Time Frame: At 5 minutes after delivery
Umbilical artery blood gases
At 5 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2025

Primary Completion (Actual)

October 1, 2025

Study Completion (Actual)

October 2, 2025

Study Registration Dates

First Submitted

July 1, 2025

First Submitted That Met QC Criteria

July 11, 2025

First Posted (Actual)

July 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caffeine and hypotension

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual Participant Data (IPD) will not be shared due to concerns regarding participant privacy and confidentiality. Although data may be de-identified, there remains a risk of re-identification, especially in studies involving small sample sizes or sensitive health information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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