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

Not Applicable

• Conditions: Epidural; Optic Nerve Sheath Diameter; Pneumoperitoneum
• Interventions: Procedure: Without epidural injection; Procedure: Epidural injection through thoracic epidural catheter

• Registration Number: NCT04758013
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-16
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-13
• Last Update Submitted: 2021-02-13
• Study First Posted: 2021-02-17
• Last Update Posted: 2021-02-17
• Primary Completion: 2021-12-16
• Study Completion: 2022-12-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic gastric surgery without Epidural injection	Without epidural injection	Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.
Laparoscopic gastric surgery with Epidural injection	Epidural injection through thoracic epidural catheter	Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.

Primary Outcome Measures

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

Trial Locations

Locations (1)

KeimyungUniversity; 🇰🇷 Daegu, Korea, Republic of