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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 16, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Laparoscopic gastric surgery with Epidural injection
    • Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.
  • Experimental: Laparoscopic gastric surgery without Epidural injection
    • Patients with laparoscopic gastric surgery who don’t received epidural injection through an thoracic epidural catheter.
  • No Intervention: Open gastric surgery
    • Patients with open gastric surgery.

Clinical Trial Outcome Measures

Primary Measures

  • T0 : Optic nerve sheath diameter
    • Time Frame: 10 minutes after anesthesia induction
    • The investigator measures Optic nerve sheath diameter by ultrasonography.
  • T1 : Optic nerve sheath diameter
    • Time Frame: 10min after entering the laparoscope
    • The investigator measures Optic nerve sheath diameter.
  • T2 : Optic nerve sheath diameter
    • Time Frame: 1hour after entering the laparoscope
    • The investigator measures Optic nerve sheath diameter.
  • T3 : Optic nerve sheath diameter
    • Time Frame: 10min after the laparoscopy comes out
    • The investigator measures Optic nerve sheath diameter.

Participating in This Clinical Trial

Inclusion Criteria

  • Gastric surgery due to cancer Exclusion Criteria:

  • Coagulopathy – Infection – Previous history of thoracic spine surgery – Ophthalmic diseases – History of increased Intracranial Pressure

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Keimyung University Dongsan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ji Seob Kim, Assistant Professor – Keimyung University Dongsan Medical Center
  • Overall Official(s)
    • JiSeob Kim, Principal Investigator, Keimyung University Dongsan Medical Center
  • Overall Contact(s)
    • JiSeob Kim, 01027487480, demiandew@naver.com

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