NCT04955925

Brief Summary

In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 31, 2021

Last Update Submit

March 15, 2023

Conditions

Optic Nerve Sheath Diameter

Outcome Measures

Primary Outcomes (1)

  • Change of the optic nerve sheath diameter

    The optic nerve sheath of each eye is observed using ultrasound, and the optic nerve sheath diameter is assessed after induction of anesthesia and at the end of surgery.

    At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery

Secondary Outcomes (2)

  • Optic nerve sheath diameter at each time point

    At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery

  • Nausea and vomiting

    At 1 hour after surgery

Study Arms (2)

Sevoflurane group

Anesthesia is maintained with sevoflurane during the surgery.

Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter

Propofol group

Anesthesia is maintained with total venous anesthesia using propofol during the surgery.

Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter

Interventions

Ultrasound examination of the optic nerve sheath diameterDIAGNOSTIC_TEST

The optic nerve sheath diameter is examined using ultrasonography.

Propofol groupSevoflurane group

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing middle ear surgery under general anesthesia

You may qualify if:

  • Patients undergoing middle ear surgery

You may not qualify if:

  • History of cerebrovascular diseases
  • Increased intracranial pressure
  • History of ophthalmic surgery or diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 31, 2021

First Posted

July 9, 2021

Study Start

July 26, 2021

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

KR(1)