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

June 19, 2020 updated by: Weilian Geng, Obstetrics & Gynecology Hospital of Fudan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Early Phase 1

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200090
        • Obstetrics & Gynecology Hospital of Fudan University

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Team Sevoflurane
Drug: Sevoflurane
In Team Sevoflurane,patients undergo sevoflurane.
Experimental: Team Propofol
Drug: Propofol
In Team Propofol ,anesthesia is maintained with propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of ultrasonographic optic nerve sheath diameter
Time Frame: from the time when patients enter into operation room to the time when the surgery ending
different 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.
from the time when patients enter into operation room to the time when the surgery ending

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.
Time Frame: from the time when patients enter into operation room to the time when the surgery ending
Mean arterial pressure was collected when measures ONSD by ultrasound.
from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.
Time Frame: from the time when patients enter into operation room to the time when the surgery ending
airway pressure was collected when measures ONSD by ultrasound.
from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.
Time Frame: from the time when patients enter into operation room to the time when the surgery ending
Recording urine volume when the surgery finished.
from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.
Time Frame: from the time when patients enter into operation room to the time when the surgery ending
Recording blood loss when the surgery finished.
from the time when patients enter into operation room to the time when the surgery ending
Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.
Time Frame: from the time when patients enter into operation room to the time when the surgery ending
Recording fluid volume when the surgery finished.
from the time when patients enter into operation room to the time when the surgery ending

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V2018-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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