NCT04339244

Brief Summary

Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure. This study is designed to measure the ONSD during RALRP under regulation of arterial pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

April 6, 2020

Last Update Submit

October 10, 2020

Conditions

Optic Nerve Sheath Diameter

Keywords

arterial pressure regulation

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath diameter change among 4 time period

    optice nerve sheath diameter change among 4 time period

    Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention

Study Arms (2)

ONSD measurement under lower blood pressure

ACTIVE COMPARATOR

ONSD measurement under mean blood pressure of 60\~70 mmHg

Other: RALRP under lower mean BP

ONSD measurement under highly normal blood pressure

ACTIVE COMPARATOR

ONSD measurement under mean blood pressure of 90\~100 mmHg

Other: RALRP under lower mean BP

Interventions

RALRP under lower mean BPOTHER

RALRP under regulation of lower mean BP

ONSD measurement under lower blood pressure

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer receiving RALRP

You may not qualify if:

  • glaucoma
  • intracranial tumor
  • previous disease elevating intracranial pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

Location

Study Officials

  • Sung Won Jung, PhD

    82532584892

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

April 1, 2020

Primary Completion

August 15, 2020

Study Completion

September 15, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

KR(1)