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

Primary Purpose

Intracranial Pressure Increase

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Optic Nerve Sheath Diameter Measurement
Sponsored by
Bagcilar Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Pressure Increase focused on measuring optic nerve sheath diameter, intracranial pressure, intraabdominal pressure, cerebral regional oxygen saturation, c-section

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bagcilar Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group General Anesthesia

Grup Spinal Anesthesia

Arm Description

C-Section under general anesthesia

C-Section under spinal anesthesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Perioperative Hemodynamic Parameters
Mean arterial pressure in mmHg
Perioperative Hemodynamic Parameters
Heart rate beat per minute

Full Information

First Posted
June 22, 2020
Last Updated
September 4, 2020
Sponsor
Bagcilar Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04446013
Brief Title
Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section
Official Title
Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bagcilar Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase
Keywords
optic nerve sheath diameter, intracranial pressure, intraabdominal pressure, cerebral regional oxygen saturation, c-section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group General Anesthesia
Arm Type
Experimental
Arm Description
C-Section under general anesthesia
Arm Title
Grup Spinal Anesthesia
Arm Type
Experimental
Arm Description
C-Section under spinal anesthesia
Intervention Type
Other
Intervention Name(s)
Optic Nerve Sheath Diameter Measurement
Intervention Description
The change in intracranial pressure via optic nerve sheath diameter measurement
Primary Outcome Measure Information:
Title
Change in Optic Nerve Sheath Diameter
Description
The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.
Time Frame
Throughout the surgery
Title
Change in regional cerebral oxygen saturation
Description
The change in regional cerebral oxygen saturation during c-section among 5 time point.
Time Frame
Throughout the surgery
Secondary Outcome Measure Information:
Title
Perioperative Hemodynamic Parameters
Description
Mean arterial pressure in mmHg
Time Frame
Throughout the surgery
Title
Perioperative Hemodynamic Parameters
Description
Heart rate beat per minute
Time Frame
Throughout the surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant and undergoing c-section operation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Can Tunalı
Organizational Affiliation
Bagcilar Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bagcilar Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34200
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18509619
Citation
Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
Results Reference
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PubMed Identifier
21523461
Citation
Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.
Results Reference
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PubMed Identifier
17325503
Citation
Yoshitani K, Kawaguchi M, Miura N, Okuno T, Kanoda T, Ohnishi Y, Kuro M. Effects of hemoglobin concentration, skull thickness, and the area of the cerebrospinal fluid layer on near-infrared spectroscopy measurements. Anesthesiology. 2007 Mar;106(3):458-62. doi: 10.1097/00000542-200703000-00009.
Results Reference
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Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section

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