Effect of Anesthetic Method on Optic Nerve Sheath Diameter in Patients Undergoing RALP

NCT ID: NCT03529643

Last Updated: 2018-09-13

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

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2018-08-22

Brief Summary

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The purpose of this study was to evaluate the effect of anesthetic method on the optic nerve sheath diameter 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 anesthesia with sevoflurane-remifentanil-dexmedetomidine and the optic nerve sheath diameter measured during anesthesia with sevoflurane-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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Anesthesia with dexmedetomidine

Anesthesia with sevoflurane-remifentanil-dexmedetomidine

Dexmedetomidine :Continuous infusion of dexmedetomidine with loading dose of 1.0 μg/kg (0.25 ml/kg) for 10 minutes, then followed by maintenance dose of 0.4 µg/kg/hr (0.1 ml/kg/hr).

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Anesthesia with sevoflurane-remifentanil-dexmedetomidine

Anesthesia without dexmedetomidine

Anesthesia with sevoflurane-remifentanil

Normal saline :Continuous infusion of normal saline with loading dose (0.25 ml/kg) for 10 minutes, then followed by maintenance dose (0.1 ml/kg/hr).

Group Type PLACEBO_COMPARATOR

Without dexmedetomidine

Intervention Type OTHER

Anesthesia with sevoflurane-remifentanil

Interventions

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Dexmedetomidine

Anesthesia with sevoflurane-remifentanil-dexmedetomidine

Intervention Type DRUG

Without dexmedetomidine

Anesthesia with sevoflurane-remifentanil

Intervention Type OTHER

Other Intervention Names

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With Dexmedetomidine With normal saline

Eligibility Criteria

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Inclusion Criteria

* Undergone a robot-assisted laparoscopic prostatectomy with a prostate - cancer
* 20 years of age or older and under 80 years of age
* Agree to participate in this study

Exclusion Criteria

* History of cerebral hemorrhage or cerebral infarction
* \< 20 years of age
* ≥ 80 years of age
* Glaucoma
* Unexpected hemodynamic instability during surgery
* Failure to measure optic nerve sheath diameter
* Convert to open surgery
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

Professor

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

Other Identifiers

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20180523

Identifier Type: -

Identifier Source: org_study_id

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