- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758013
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Daegu, Korea, Republic of
- Recruiting
- KeimyungUniversity
-
Contact:
- JiSeob Kim
- Phone Number: 01027487480
- Email: demiandew@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gastric surgery due to cancer
Exclusion Criteria:
- Coagulopathy
- Infection
- Previous history of thoracic spine surgery
- Ophthalmic diseases
- History of increased Intracranial Pressure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Laparoscopic gastric surgery with Epidural injection
Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
|
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.
|
EXPERIMENTAL: Laparoscopic gastric surgery without Epidural injection
Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
|
The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.
|
NO_INTERVENTION: Open gastric surgery
Patients with open gastric surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T0 : Optic nerve sheath diameter
Time Frame: 10 minutes after anesthesia induction
|
The investigator measures Optic nerve sheath diameter by ultrasonography.
|
10 minutes after anesthesia induction
|
T1 : Optic nerve sheath diameter
Time Frame: 10min after entering the laparoscope
|
The investigator measures Optic nerve sheath diameter.
|
10min after entering the laparoscope
|
T2 : Optic nerve sheath diameter
Time Frame: 1hour after entering the laparoscope
|
The investigator measures Optic nerve sheath diameter.
|
1hour after entering the laparoscope
|
T3 : Optic nerve sheath diameter
Time Frame: 10min after the laparoscopy comes out
|
The investigator measures Optic nerve sheath diameter.
|
10min after the laparoscopy comes out
|
Collaborators and Investigators
Investigators
- Principal Investigator: JiSeob Kim, Keimyung University Dongsan Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KeimyungUniversity
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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