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Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Laparoscopic Gynecologic Surgery

Randomized,Double-Blind Trial A Comparative Analysis of the Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Steep Trendelenburg Position and Pneumoperitoneum for Laparoscopic Gynecologic Surgery

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498235
Enrollment
110
Registered
2018-04-13
Start date
2018-03-01
Completion date
2020-06-30
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Gynecologic Surgery

Keywords

sevoflurane, propofol, intracranial pressure, optic nerve sheath diameter

Brief summary

Intracranial pressure(ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.

Detailed description

Due to the anatomical and physiological characteristics of optic nerve sheath ,ONSD increases when ICP rises. Sevoflurane and propofol have different effects on ICP.When sevoflurane concentration \>1.1 minimum alveolar concentration(MAC),ICP increases because of cerebral vasodilatation;on the other hand ,propofol constricts the blood vessels and ICP decreases. ICP increases during laparoscopic gynecologic surgery because of steep Trendelenburg position and pneumoperitoneum . Meanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.

Interventions

DRUGSevoflurane

In Team Sevoflurane,patients undergo sevoflurane.

DRUGPropofol

In Team Propofol ,anesthesia is maintained with propofol

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists physical status diagnosed as I or II

Exclusion criteria

* neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.

Design outcomes

Primary

MeasureTime frameDescription
Changes of ultrasonographic optic nerve sheath diameterfrom the time when patients enter into operation room to the time when the surgery endingdifferent time including pre-anesthesia, after intubation,every 15 minutes in the first hour after beginning of surgery, every hour when one hour after surgery beginning,surgery ending.

Secondary

MeasureTime frameDescription
Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.from the time when patients enter into operation room to the time when the surgery endingMean arterial pressure was collected when measures ONSD by ultrasound.
Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.from the time when patients enter into operation room to the time when the surgery endingairway pressure was collected when measures ONSD by ultrasound.
Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.from the time when patients enter into operation room to the time when the surgery endingRecording urine volume when the surgery finished.
Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.from the time when patients enter into operation room to the time when the surgery endingRecording blood loss when the surgery finished.
Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.from the time when patients enter into operation room to the time when the surgery endingRecording fluid volume when the surgery finished.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026