NCT04446013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

June 22, 2020

Last Update Submit

September 4, 2020

Conditions

Intracranial Pressure Increase

Keywords

optic nerve sheath diameterintracranial pressureintraabdominal pressurecerebral regional oxygen saturationc-section

Outcome Measures

Primary Outcomes (2)

  • Change in Optic Nerve Sheath Diameter

    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

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

    Throughout the surgery

Secondary Outcomes (2)

  • Perioperative Hemodynamic Parameters

    Throughout the surgery

  • Perioperative Hemodynamic Parameters

    Throughout the surgery

Study Arms (2)

Group General Anesthesia

EXPERIMENTAL

C-Section under general anesthesia

Other: Optic Nerve Sheath Diameter Measurement

Grup Spinal Anesthesia

EXPERIMENTAL

C-Section under spinal anesthesia

Other: Optic Nerve Sheath Diameter Measurement

Interventions

Optic Nerve Sheath Diameter MeasurementOTHER

The change in intracranial pressure via optic nerve sheath diameter measurement

Group General AnesthesiaGrup Spinal Anesthesia

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant and undergoing c-section operation
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 18509619BACKGROUND

  • 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.

    PMID: 21523461BACKGROUND

  • 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.

    PMID: 17325503BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mehmet Can Tunalı

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

May 15, 2020

Primary Completion

June 25, 2020

Study Completion

July 30, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

TU(1)