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

NCT ID: NCT03498235

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Laparoscopic Gynecologic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Team Sevoflurane

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

In Team Sevoflurane,patients undergo sevoflurane.

Team Propofol

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

In Team Propofol ,anesthesia is maintained with propofol

Interventions

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Sevoflurane

In Team Sevoflurane,patients undergo sevoflurane.

Intervention Type DRUG

Propofol

In Team Propofol ,anesthesia is maintained with propofol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Obstetrics & Gynecology Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Weilian Geng

Director,Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Geng W, Chen C, Sun X, Huang S. Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies. BMC Anesthesiol. 2021 Jan 27;21(1):30. doi: 10.1186/s12871-021-01243-7.

Reference Type DERIVED
PMID: 33504329 (View on PubMed)

Other Identifiers

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V2018-2

Identifier Type: -

Identifier Source: org_study_id

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