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

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04758013

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Optic Nerve Sheath Diameter Pneumoperitoneum Epidural	Procedure: Epidural injection through thoracic epidural catheter Procedure: Without epidural injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 16, 2020

Anticipated Primary Completion Date :

Dec 16, 2021

Anticipated Study Completion Date :

Dec 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic gastric surgery with Epidural injection Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.	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.
Experimental: Laparoscopic gastric surgery without Epidural injection Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.	Procedure: Without epidural injection 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.

Arm

Intervention/Treatment

Experimental: Laparoscopic gastric surgery with Epidural injection

Patients with laparoscopic gastric surgery who received epidural injection through an thoracic epidural catheter.

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.

Experimental: Laparoscopic gastric surgery without Epidural injection

Patients with laparoscopic gastric surgery who don't received epidural injection through an thoracic epidural catheter.

Procedure: Without epidural injection

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Gastric surgery due to cancer

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KeimyungUniversity	Daegu		Korea, Republic of

Sponsors and Collaborators

Keimyung University Dongsan Medical Center

Investigators

Principal Investigator: JiSeob Kim, Keimyung University Dongsan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji Seob Kim, Assistant Professor, Keimyung University Dongsan Medical Center

ClinicalTrials.gov Identifier:

NCT04758013

Other Study ID Numbers:

KeimyungUniversity

First Posted:

Feb 17, 2021

Last Update Posted:

Feb 17, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ji Seob Kim, Assistant Professor, Keimyung University Dongsan Medical Center

ONSD

pneumoperitoneum

epidural

Additional relevant MeSH terms:

Pneumoperitoneum

Study Results

No Results Posted as of Feb 17, 2021