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

NCT ID: NCT04758013

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-16

Study Completion Date

2022-12-16

Brief Summary

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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

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Conditions

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Optic Nerve Sheath Diameter Pneumoperitoneum Epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Laparoscopic gastric surgery with Epidural injection

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

Group Type EXPERIMENTAL

Epidural injection through thoracic epidural catheter

Intervention Type PROCEDURE

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.

Laparoscopic gastric surgery without Epidural injection

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

Group Type EXPERIMENTAL

Without epidural injection

Intervention Type PROCEDURE

The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.

Open gastric surgery

Patients with open gastric surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Without epidural injection

The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Gastric surgery due to cancer

Exclusion Criteria

* Coagulopathy
* Infection
* Previous history of thoracic spine surgery
* Ophthalmic diseases
* History of increased Intracranial Pressure
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ji Seob Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JiSeob Kim

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

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KeimyungUniversity

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JiSeob Kim

Role: CONTACT

01027487480

Facility Contacts

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JiSeob Kim

Role: primary

01027487480

References

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Kim JS, Hong JH, Park JH. Comparison of Changes in the Optic Nerve Sheath Diameter Following Thoracic Epidural Normal Saline Injection in Laparoscopic Surgery. Pain Physician. 2022 Jul;25(4):E563-E569.

Reference Type DERIVED
PMID: 35793180 (View on PubMed)

Other Identifiers

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KeimyungUniversity

Identifier Type: -

Identifier Source: org_study_id

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