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

September 4, 2020 updated by: Bagcilar Training and Research Hospital

Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34200
        • Bagcilar Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group General Anesthesia
C-Section under general anesthesia
Other: Optic Nerve Sheath Diameter Measurement
The change in intracranial pressure via optic nerve sheath diameter measurement
EXPERIMENTAL: Grup Spinal Anesthesia
C-Section under spinal anesthesia
Other: Optic Nerve Sheath Diameter Measurement
The change in intracranial pressure via optic nerve sheath diameter measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Throughout the surgery
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.
Throughout the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Hemodynamic Parameters
Time Frame: Throughout the surgery
Mean arterial pressure in mmHg
Throughout the surgery
Perioperative Hemodynamic Parameters
Time Frame: Throughout the surgery
Heart rate beat per minute
Throughout the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Investigators

  • Principal Investigator: Mehmet Can Tunalı, Bagcilar Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2020

Primary Completion (ACTUAL)

June 25, 2020

Study Completion (ACTUAL)

July 30, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (ACTUAL)

June 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020.05.1.16.048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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