NCT03498235

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2018

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

March 8, 2018

Last Update Submit

June 19, 2020

Conditions

Laparoscopic Gynecologic Surgery

Keywords

sevofluranepropofolintracranial pressureoptic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

  • Changes of ultrasonographic optic nerve sheath diameter

    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 Outcomes (5)

  • 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 ending

  • 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 ending

  • 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 ending

  • 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 ending

  • 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 ending

Study Arms (2)

Team Sevoflurane

EXPERIMENTAL
Drug: Sevoflurane

Team Propofol

EXPERIMENTAL
Drug: Propofol

Interventions

SevofluraneDRUG

In Team Sevoflurane,patients undergo sevoflurane.

Team Sevoflurane
PropofolDRUG

In Team Propofol ,anesthesia is maintained with propofol

Team Propofol

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

Location

Related Publications (1)

  • 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.

    PMID: 33504329DERIVED

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Clinical Research

Study Record Dates

First Submitted

March 8, 2018

First Posted

April 13, 2018

Study Start

March 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)