Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
Primary Purpose
Optic Nerve Sheath Diameter, Pneumoperitoneum, Epidural
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epidural injection through thoracic epidural catheter
Without epidural injection
Sponsored by
About this trial
This is an interventional supportive care trial for Optic Nerve Sheath Diameter focused on measuring ONSD, pneumoperitoneum, epidural
Eligibility Criteria
Inclusion Criteria:
- Gastric surgery due to cancer
Exclusion Criteria:
- Coagulopathy
- Infection
- Previous history of thoracic spine surgery
- Ophthalmic diseases
- History of increased Intracranial Pressure
Sites / Locations
- KeimyungUniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Laparoscopic gastric surgery with Epidural injection
Laparoscopic gastric surgery without Epidural injection
Open gastric surgery
Arm Description
Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
Patients with open gastric surgery.
Outcomes
Primary Outcome Measures
T0 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter by ultrasonography.
T1 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter.
T2 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter.
T3 : Optic nerve sheath diameter
The investigator measures Optic nerve sheath diameter.
Secondary Outcome Measures
Full Information
NCT ID
NCT04758013
First Posted
February 8, 2021
Last Updated
February 13, 2021
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04758013
Brief Title
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
Official Title
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
December 16, 2021 (Anticipated)
Study Completion Date
December 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
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
This study targets patients undergoing laparoscopic gastric cancer surgery.
The investigators would like to compare two factors that influence intracranial pressure through optic nerve sheath diameter measurement.
First factor is intraperitoneal pressure.
Second factor is epidural pressure.
The investigators divided the patients into three groups.
Group A is patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
Group B is patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
Group C is patients with open gastric surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Nerve Sheath Diameter, Pneumoperitoneum, Epidural
Keywords
ONSD, pneumoperitoneum, epidural
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic gastric surgery with Epidural injection
Arm Type
Experimental
Arm Description
Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
Arm Title
Laparoscopic gastric surgery without Epidural injection
Arm Type
Experimental
Arm Description
Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
Arm Title
Open gastric surgery
Arm Type
No Intervention
Arm Description
Patients with open gastric surgery.
Intervention Type
Procedure
Intervention Name(s)
Epidural injection through thoracic epidural catheter
Intervention Description
The investigators inject drugs through a catheter inserted into the thoracic epidural space to control pain after surgery in patients undergoing gastric surgery by laparoscopy.
Intervention Type
Procedure
Intervention Name(s)
Without epidural injection
Intervention Description
The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.
Primary Outcome Measure Information:
Title
T0 : Optic nerve sheath diameter
Description
The investigator measures Optic nerve sheath diameter by ultrasonography.
Time Frame
10 minutes after anesthesia induction
Title
T1 : Optic nerve sheath diameter
Description
The investigator measures Optic nerve sheath diameter.
Time Frame
10min after entering the laparoscope
Title
T2 : Optic nerve sheath diameter
Description
The investigator measures Optic nerve sheath diameter.
Time Frame
1hour after entering the laparoscope
Title
T3 : Optic nerve sheath diameter
Description
The investigator measures Optic nerve sheath diameter.
Time Frame
10min after the laparoscopy comes out
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gastric surgery due to cancer
Exclusion Criteria:
Coagulopathy
Infection
Previous history of thoracic spine surgery
Ophthalmic diseases
History of increased Intracranial Pressure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JiSeob Kim
Phone
01027487480
Email
demiandew@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JiSeob Kim
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
KeimyungUniversity
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiSeob Kim
Phone
01027487480
Email
demiandew@naver.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35793180
Citation
Kim JS, Hong JH, Park JH. Comparison of Changes in the Optic Nerve Sheath Diameter Following Thoracic Epidural Normal Saline Injection in Laparoscopic Surgery. Pain Physician. 2022 Jul;25(4):E563-E569.
Results Reference
derived
Learn more about this trial
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
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