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

Not Applicable

Completed

• Conditions: Intracranial Pressure Increase
• Interventions: Other: Optic Nerve Sheath Diameter Measurement

• Registration Number: NCT04446013
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-24
• Primary Completion: 2020-06-25
• Study Completion: 2020-07-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup Spinal Anesthesia	Optic Nerve Sheath Diameter Measurement	C-Section under spinal anesthesia
Group General Anesthesia	Optic Nerve Sheath Diameter Measurement	C-Section under general anesthesia

Primary Outcome Measures

Name	Time	Method
Change in Optic Nerve Sheath Diameter	Throughout the surgery	The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.
Change in regional cerebral oxygen saturation	Throughout the surgery	The change in regional cerebral oxygen saturation during c-section among 5 time point.

Secondary Outcome Measures

Name	Time	Method
Perioperative Hemodynamic Parameters	Throughout the surgery	Heart rate beat per minute

Trial Locations

Locations (1)

Bagcilar Training and Research Hospital; 🇹🇷 Istanbul, Turkey