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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Laparoscopic Gynecologic Surgery

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Team Sevoflurane<br> | Drug: Sevoflurane<br>* In Team Sevoflurane,patients undergo sevoflurane.<br>|
| Experimental: Team Propofol<br> | Drug: Propofol<br>* In Team Propofol ,anesthesia is maintained with propofol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 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. | 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. | 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. | 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. | Recording fluid volume when the surgery finished. | from the time when patients enter into operation room to the time when the surgery ending | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, propofol, intracranial pressure, optic nerve sheath diameter