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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498235
Recruitment Status : Unknown
Verified March 2018 by Weilian Geng, Obstetrics & Gynecology Hospital of Fudan University.
Recruitment status was:  Enrolling by invitation
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Weilian Geng, 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Gynecologic Surgery Drug: Sevoflurane Drug: Propofol Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Team Sevoflurane Drug: Sevoflurane
In Team Sevoflurane,patients undergo sevoflurane.

Experimental: Team Propofol Drug: Propofol
In Team Propofol ,anesthesia is maintained with propofol




Primary Outcome Measures :
  1. Changes of ultrasonographic optic nerve sheath diameter [ Time Frame: 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 :
  1. Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups. [ Time Frame: 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.

  2. Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups. [ Time Frame: 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.

  3. Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups. [ Time Frame: from the time when patients enter into operation room to the time when the surgery ending ]
    Recording urine volume when the surgery finished.

  4. Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups. [ Time Frame: from the time when patients enter into operation room to the time when the surgery ending ]
    Recording blood loss when the surgery finished.

  5. Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups. [ Time Frame: from the time when patients enter into operation room to the time when the surgery ending ]
    Recording fluid volume when the surgery finished.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498235


Locations
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China, Shanghai
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai, China, 200090
Sponsors and Collaborators
Obstetrics & Gynecology Hospital of Fudan University

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Responsible Party: Weilian Geng, Director,Clinical Research, Obstetrics & Gynecology Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03498235    
Other Study ID Numbers: V2018-2
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weilian Geng, Obstetrics & Gynecology Hospital of Fudan University:
sevoflurane
propofol
intracranial pressure
optic nerve sheath diameter
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation