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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758013
Enrollment
60
Registered
2021-02-17
Start date
2020-12-16
Completion date
2022-12-16
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural, Optic Nerve Sheath Diameter, Pneumoperitoneum

Keywords

ONSD, pneumoperitoneum, epidural

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.

Interventions

PROCEDUREEpidural 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.

PROCEDUREWithout epidural injection

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

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
T0 : Optic nerve sheath diameter10 minutes after anesthesia inductionThe investigator measures Optic nerve sheath diameter by ultrasonography.
T1 : Optic nerve sheath diameter10min after entering the laparoscopeThe investigator measures Optic nerve sheath diameter.
T2 : Optic nerve sheath diameter1hour after entering the laparoscopeThe investigator measures Optic nerve sheath diameter.
T3 : Optic nerve sheath diameter10min after the laparoscopy comes outThe investigator measures Optic nerve sheath diameter.

Countries

South Korea

Contacts

Primary ContactJiSeob Kim
demiandew@naver.com01027487480

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026