Back to resultsEffect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Total intravenous anesthesia
Inhalation anesthesia
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.
Exclusion Criteria:
Patients with a history of cerebral hemorrhage or cerebral infarction, Patients < 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Total intravenous anesthesia
Inhalation anesthesia
Arm Description
Total intravenous anesthesia with propofol and remifentanil
Inhalation anesthesia with sevoflurane and remifentanil
Outcomes
Primary Outcome Measures
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Secondary Outcome Measures
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Difference in optic nerve sheath diameter
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03271502
Brief Title
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Official Title
Effect of Inhalation Anesthesia With Sevoflurane and Total Intravenous Anesthesia With Propofol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 26, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.
Detailed Description
The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total intravenous anesthesia
Arm Type
Experimental
Arm Description
Total intravenous anesthesia with propofol and remifentanil
Arm Title
Inhalation anesthesia
Arm Type
Active Comparator
Arm Description
Inhalation anesthesia with sevoflurane and remifentanil
Intervention Type
Procedure
Intervention Name(s)
Total intravenous anesthesia
Intervention Description
Total intravenous anesthesia with propofol and remifentanil
Intervention Type
Procedure
Intervention Name(s)
Inhalation anesthesia
Intervention Description
Inhalation anesthesia with sevoflurane and remifentanil
Primary Outcome Measure Information:
Title
Difference in optic nerve sheath diameter
Description
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Time Frame
60 minutes after pneumoperitoneum and steep Trendelenburg position
Secondary Outcome Measure Information:
Title
Difference in optic nerve sheath diameter
Description
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Time Frame
30 minutes after pneumoperitoneum and steep Trendelenburg position
Title
Difference in optic nerve sheath diameter
Description
Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
Time Frame
5 minutes after pneumoperitoneum and steep Trendelenburg position
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.
Exclusion Criteria:
Patients with a history of cerebral hemorrhage or cerebral infarction, Patients < 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD,PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29925316
Citation
Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.
Results Reference
derived
Learn more about this trial
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
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