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NCT04758013 Clinical Trial

Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection

Pneumoperitoneum Clinical Trial

Official title:
Comparison of Changes of ONSD Between Groups of Laparoscopic Surgery With and Without Epidural Saline Injection

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04758013
Other study ID # KeimyungUniversity
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 16, 2020
Est. completion date December 16, 2022

Study information
Verified date February 2021
Source Keimyung University Dongsan Medical Center
Contact JiSeob Kim
Phone 01027487480
Email demiandew@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 16, 2022
Est. primary completion date December 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Epidural injection through 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.
• Without epidural injection
The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.

Locations
Country Name City State
Korea, Republic of KeimyungUniversity Daegu

Sponsors (1)
Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary T0 : Optic nerve sheath diameter The investigator measures Optic nerve sheath diameter by ultrasonography. 10 minutes after anesthesia induction
Primary T1 : Optic nerve sheath diameter The investigator measures Optic nerve sheath diameter. 10min after entering the laparoscope
Primary T2 : Optic nerve sheath diameter The investigator measures Optic nerve sheath diameter. 1hour after entering the laparoscope
Primary T3 : Optic nerve sheath diameter The investigator measures Optic nerve sheath diameter. 10min after the laparoscopy comes out
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