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

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ClinicalTrials.gov Identifier: NCT04758013
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Ji Seob Kim, Keimyung University Dongsan Medical Center

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 16, 2020
Estimated Primary Completion Date : December 16, 2021
Estimated Study Completion Date : December 16, 2022
Arms and Interventions
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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
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Primary Outcome Measures :
  1. T0 : Optic nerve sheath diameter [ Time Frame: 10 minutes after anesthesia induction ]
    The investigator measures Optic nerve sheath diameter by ultrasonography.

  2. T1 : Optic nerve sheath diameter [ Time Frame: 10min after entering the laparoscope ]
    The investigator measures Optic nerve sheath diameter.

  3. T2 : Optic nerve sheath diameter [ Time Frame: 1hour after entering the laparoscope ]
    The investigator measures Optic nerve sheath diameter.

  4. T3 : Optic nerve sheath diameter [ Time Frame: 10min after the laparoscopy comes out ]
    The investigator measures Optic nerve sheath diameter.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758013


Contacts
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Contact: JiSeob Kim 01027487480 demiandew@naver.com

Locations
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Korea, Republic of
KeimyungUniversity Recruiting
Daegu, Korea, Republic of
Contact: JiSeob Kim    01027487480    demiandew@naver.com   
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: JiSeob Kim Keimyung University Dongsan Medical Center
More Information
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Responsible Party: Ji Seob Kim, Assistant Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT04758013    
Other Study ID Numbers: KeimyungUniversity
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Seob Kim, Keimyung University Dongsan Medical Center:
ONSD
pneumoperitoneum
epidural
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases