NCT04758013

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 8, 2021

Last Update Submit

February 13, 2021

Conditions

Optic Nerve Sheath DiameterPneumoperitoneumEpidural

Keywords

ONSDpneumoperitoneumepidural

Outcome Measures

Primary Outcomes (4)

  • T0 : Optic nerve sheath diameter

    The investigator measures Optic nerve sheath diameter by ultrasonography.

    10 minutes after anesthesia induction

  • T1 : Optic nerve sheath diameter

    The investigator measures Optic nerve sheath diameter.

    10min after entering the laparoscope

  • T2 : Optic nerve sheath diameter

    The investigator measures Optic nerve sheath diameter.

    1hour after entering the laparoscope

  • T3 : Optic nerve sheath diameter

    The investigator measures Optic nerve sheath diameter.

    10min after the laparoscopy comes out

Study Arms (3)

Laparoscopic gastric surgery with Epidural injection

EXPERIMENTAL

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

Procedure: Epidural injection through thoracic epidural catheter

Laparoscopic gastric surgery without Epidural injection

EXPERIMENTAL

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

Procedure: Without epidural injection

Open gastric surgery

NO INTERVENTION

Patients with open gastric surgery.

Interventions

Epidural injection through thoracic epidural catheterPROCEDURE

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 with Epidural injection
Without epidural injectionPROCEDURE

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

Laparoscopic gastric surgery without Epidural injection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric surgery due to cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KeimyungUniversity

Daegu, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35793180DERIVED

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • JiSeob Kim

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JiSeob Kim

CONTACT

01027487480demiandew@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 17, 2021

Study Start

December 16, 2020

Primary Completion

December 16, 2021

Study Completion

December 16, 2022

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

KR(1)