Clinical trial NCT03498235: Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Laparoscopic Gynecologic Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Laparoscopic Gynecologic Surgery
Keywords: sevoflurane
propofol
intracranial pressure
optic nerve sheath diameter
Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of ultrasonographic optic nerve sheath diameter
timeFrame: from the time when patients enter into operation room to the time when the surgery ending
Secondary outcomes:
measure: Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.
timeFrame: from the time when patients enter into operation room to the time when the surgery ending
measure: Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.
timeFrame: from the time when patients enter into operation room to the time when the surgery ending
measure: Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.
timeFrame: from the time when patients enter into operation room to the time when the surgery ending
measure: Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.
timeFrame: from the time when patients enter into operation room to the time when the surgery ending
measure: Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.
timeFrame: from the time when patients enter into operation room to the time when the surgery ending
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics & Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: 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.