Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter
March 15, 2023 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
Comparison of the Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Middle Ear Surgery
In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
58
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
-
-
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Seoul, Korea, Republic of
- SMG-SNU Boramae Medical Center
-
-
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing middle ear surgery under general anesthesia
Description
Inclusion Criteria:
- Patients undergoing middle ear surgery
Exclusion Criteria:
- History of cerebrovascular diseases
- Increased intracranial pressure
- History of ophthalmic surgery or diseases
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sevoflurane group
Anesthesia is maintained with sevoflurane during the surgery.
|
The optic nerve sheath diameter is examined using ultrasonography.
|
|
Propofol group
Anesthesia is maintained with total venous anesthesia using propofol during the surgery.
|
The optic nerve sheath diameter is examined using ultrasonography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of the optic nerve sheath diameter
Time Frame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optic nerve sheath diameter at each time point
Time Frame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
|
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
|
|
Nausea and vomiting
Time Frame: At 1 hour after surgery
|
Presence and severity of nausea and vomiting is assessed.
|
At 1 hour after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 26, 2021
Primary Completion (Actual)
August 18, 2022
Study Completion (Actual)
August 18, 2022
Study Registration Dates
First Submitted
March 31, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 9, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 03-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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