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

Laparoscopic Gynecologic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03498235
• Other study ID #: V2018-2
• Status: Enrolling by invitation
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Laparoscopic Gynecologic Surgery

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