NCT03271502

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable prostate-cancer

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

First Submitted

Initial submission to the registry

August 31, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

22 days

First QC Date

August 31, 2017

Last Update Submit

October 25, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Difference in optic nerve sheath diameter

    Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia

    60 minutes after pneumoperitoneum and steep Trendelenburg position

Secondary Outcomes (2)

  • Difference in optic nerve sheath diameter

    30 minutes after pneumoperitoneum and steep Trendelenburg position

  • Difference in optic nerve sheath diameter

    5 minutes after pneumoperitoneum and steep Trendelenburg position

Study Arms (2)

Total intravenous anesthesia

EXPERIMENTAL

Total intravenous anesthesia with propofol and remifentanil

Procedure: Total intravenous anesthesia

Inhalation anesthesia

ACTIVE COMPARATOR

Inhalation anesthesia with sevoflurane and remifentanil

Procedure: Inhalation anesthesia

Interventions

Total intravenous anesthesiaPROCEDURE

Total intravenous anesthesia with propofol and remifentanil

Total intravenous anesthesia
Inhalation anesthesiaPROCEDURE

Inhalation anesthesia with sevoflurane and remifentanil

Inhalation anesthesia

Eligibility Criteria

Age20 Years - 79 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29925316DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Anesthesia, Inhalation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, GeneralAnesthesiaAnesthesia and Analgesia

Study Officials

  • Young-Kug Kim, MD,PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

September 4, 2017

Primary Completion

September 26, 2017

Study Completion

October 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

KR(1)