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Completed

NCT Number: NCT07076654

Oral Caffeine and Spinal-Induced Hypotension

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

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Key information

Conditions

Spinal Hypotension Caffeine

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 6890, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine (200 mg)

Drug

Oral caffeine will be given as 200 mg before spinal anesthesia

Placebo

Drug

Patient at this arm will receive placebo

Primary outcomes

  1. Incidence of spinal hypotension

    Time frame: After spinal anesthesia till delivery

    Decrease systolic blood pressure < 20% of baseline value

Secondary outcomes

  1. Time to first hypotensive episode

    Time frame: after induction of spinal anesthesia

    time to incidence of hypotension

  2. Incidence of severe hypotension

    Time frame: After onset of spinal anesthesia

    reduced systolic pressure < 60% of baseline value

  3. APGAR score

    Time frame: at 5 minutes after delivery

    APGAR score calculation at 5 minutes

  4. Umbilical artery pH

    Time frame: At 5 minutes after delivery

    Umbilical artery blood gases

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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