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Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy

NCT ID: NCT03271502

Last Updated: 2017-10-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2017-10-01

Brief Summary

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The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed Description

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The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Total intravenous anesthesia

Total intravenous anesthesia with propofol and remifentanil

Group Type EXPERIMENTAL

Total intravenous anesthesia

Intervention Type PROCEDURE

Total intravenous anesthesia with propofol and remifentanil

Inhalation anesthesia

Inhalation anesthesia with sevoflurane and remifentanil

Group Type ACTIVE_COMPARATOR

Inhalation anesthesia

Intervention Type PROCEDURE

Inhalation anesthesia with sevoflurane and remifentanil

Interventions

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Total intravenous anesthesia

Total intravenous anesthesia with propofol and remifentanil

Intervention Type PROCEDURE

Inhalation anesthesia

Inhalation anesthesia with sevoflurane and remifentanil

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.

Exclusion Criteria

Patients with a history of cerebral hemorrhage or cerebral infarction, Patients \< 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.

Reference Type DERIVED
PMID: 29925316 (View on PubMed)

Other Identifiers

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2017-1011

Identifier Type: -

Identifier Source: org_study_id