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

Early Phase 1

• Conditions: Laparoscopic Gynecologic Surgery
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT03498235
• Lead Sponsor: Obstetrics & Gynecology Hospital of Fudan University

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.

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 Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Status Verified: 2020-06
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Team Sevoflurane	Sevoflurane	-
Team Propofol	Propofol	-

Primary Outcome Measures

Name	Time	Method
Changes of ultrasonographic optic nerve sheath diameter	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.

Secondary Outcome Measures

Name	Time	Method
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	Mean arterial pressure was collected when measures ONSD by ultrasound.
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	airway pressure was collected when measures ONSD by ultrasound.
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	Recording urine volume when the surgery finished.
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	Recording blood loss when the surgery finished.
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	Recording fluid volume when the surgery finished.

Trial Locations

Locations (1)

Obstetrics & Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China