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Completed

NCT Number: NCT04446013

Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section

General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal intubation and mechanical ventilation are components of general anesthesia. Endotracheal intubation has been shown to cause increased intracranial pressure. There is not enough information about the effect of spinal anesthesia on intracranial pressure during cesarean operations. Increased intracranial pressure can cause neurological complications by disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia method should be determined especially in pregnant patients who are at risk of increased intracranial pressure.

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Key information

Conditions

Intracranial Pressure Increase Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Undergoing elective c-section operation
  • Age between 18-49
  • ASA I-II
  • Gestational week ≥ 36

Exclusion criteria

  • Ophthalmologic disease and optic nerve pathology
  • Increased intracranial pressure
  • History of cerebrovascular disease
  • Cases where spinal anesthesia is contraindicated
  • Emergency cesarean category level 1

Treatment and study plan

Optic Nerve Sheath Diameter Measurement

Other

The change in intracranial pressure via optic nerve sheath diameter measurement

Primary outcomes

  1. Change in Optic Nerve Sheath Diameter

    Time frame: Throughout the surgery

    The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.

  2. Change in regional cerebral oxygen saturation

    Time frame: Throughout the surgery

    The change in regional cerebral oxygen saturation during c-section among 5 time point.

Secondary outcomes

  1. Perioperative Hemodynamic Parameters

    Time frame: Throughout the surgery

    Mean arterial pressure in mmHg

  2. Perioperative Hemodynamic Parameters

    Time frame: Throughout the surgery

    Heart rate beat per minute

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 24, 2020
Registry last updated
Sep 9, 2020

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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