Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
Primary Purpose
Uterus Myoma, Uterine Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
About this trial
This is an interventional supportive care trial for Uterus Myoma
Eligibility Criteria
Inclusion Criteria:
- female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy
Exclusion Criteria:
- history of brain hemorrhage or brain infarction
- liver disease or end stage renal disease
- glaucoma or any signs of increased intraocular pressure
- combined wtih other types of operation
- patient refusal
- weight less than 40 kg or over 100 kg
Sites / Locations
- Kangnam Sungshim Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevoflurane
Propofol
Arm Description
1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia.
2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system.
Outcomes
Primary Outcome Measures
difference of optic nerve sheath diameter
optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)
Secondary Outcome Measures
Full Information
NCT ID
NCT03701529
First Posted
October 8, 2018
Last Updated
September 2, 2020
Sponsor
Hallym University Kangnam Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03701529
Brief Title
Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
Official Title
Effect of Anesthetic Agents (Propofol, Sevoflurane) on Optic Nerve Sheath Diameter(ONSD) in Patients Undergoing Robot-assisted Laparoscopic Gynecology Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
September 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Kangnam Sacred Heart Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery.
Detailed Description
Anesthetic agents (propofol and sevoflurane)have different effect on intracranial pressure. Sevoflurane when used over 0.5 minimum alveolar concentration, dilates intracranial vasculature and increases intracranial pressure. On the other hand, propofol decreases intracranial blood pressure and intracranial pressure is maintained or decreases.
Optic nerve sheath diameter is a feasible diagnostic tool in evaluating intracranial pressure. Female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy are evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterus Myoma, Uterine Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
1.5-2.5 vol% of sevoflurane is used for maintenance of anesthesia.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
2-5 mcg/ml of propofol is used continuously for maintenance of anesthesia using target-controlled infusion system.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
sevoflurane anesthesia
Intervention Description
1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
propofol anesthesia
Intervention Description
2-5 mcg/ml of propofol is used for maintenance of anesthesia.
Primary Outcome Measure Information:
Title
difference of optic nerve sheath diameter
Description
optic nerve sheath diameter is measured using sonographic probe. (10 minutes after induction of anesthesia/ 5 minutes after pneumoperitoneum and trendelenburg position / 20 minutes after pneumoperitoneum and trendelenburg position / 40 minutes after pneumoperitoneum and trendelenburg position / skin closure)
Time Frame
During the operation.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy
Exclusion Criteria:
history of brain hemorrhage or brain infarction
liver disease or end stage renal disease
glaucoma or any signs of increased intraocular pressure
combined wtih other types of operation
patient refusal
weight less than 40 kg or over 100 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choi Eun-Mi, Professor
Organizational Affiliation
Kangnam Sungshim Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kangnam Sungshim Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Anesthetic Agents on Optic Nerve Sheath Diameter
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