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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03498235
Other study ID # V2018-2
Secondary ID
Status Enrolling by invitation
Phase Early Phase 1
First received
Last updated
Start date March 1, 2018
Est. completion date June 2020

Study information

Verified date June 2020
Source Obstetrics & Gynecology Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 110
Est. completion date June 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
In Team Sevoflurane,patients undergo sevoflurane.
Propofol
In Team Propofol ,anesthesia is maintained with propofol

Locations

Country Name City State
China Obstetrics & Gynecology Hospital of Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Obstetrics & Gynecology Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups. 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
Secondary Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups. 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
Secondary Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups. Recording urine volume when the surgery finished. from the time when patients enter into operation room to the time when the surgery ending
Secondary Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups. Recording blood loss when the surgery finished. from the time when patients enter into operation room to the time when the surgery ending
Secondary Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups. Recording fluid volume when the surgery finished. from the time when patients enter into operation room to the time when the surgery ending
See also
  Status Clinical Trial Phase
Completed NCT01534416 - Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery N/A
Completed NCT04348357 - Utilizing Telemedicine for Delivery of Postoperative Care N/A
Completed NCT01379313 - The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position N/A