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Oral Caffeine and Spinal-Induced Hypotension

NCT ID: NCT07076654

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2025-10-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Spinal Hypotension Caffeine

Keywords

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Spinal hypotension Caffeine Cesarean delivery

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Caffeine

Patients will receive oral caffeine 200 mg before spinal anesthesia

Group Type ACTIVE_COMPARATOR

Caffeine (200 mg)

Intervention Type DRUG

Oral caffeine will be given as 200 mg before spinal anesthesia

Control group

Will receive placebo before spinal anesthesia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patient at this arm will receive placebo

Interventions

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Caffeine (200 mg)

Oral caffeine will be given as 200 mg before spinal anesthesia

Intervention Type DRUG

Placebo

Patient at this arm will receive placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mina Adolf Helmy

Lecturer of anesthesia and critical care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 28826374 (View on PubMed)

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.

Reference Type RESULT
PMID: 40318850 (View on PubMed)

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.

Reference Type RESULT
PMID: 40550198 (View on PubMed)

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.

Reference Type RESULT
PMID: 39848332 (View on PubMed)

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.

Reference Type RESULT
PMID: 29090733 (View on PubMed)

Other Identifiers

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Caffeine and hypotension

Identifier Type: -

Identifier Source: org_study_id