NCT02697825

Brief Summary

This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath Diameter in steep trendelenburg position. Both observations will be done in same patient over the surgical duration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 20, 2016

Last Update Submit

February 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • correlation between rise of intraocular pressure and optic nerve sheath diameter

    Intraocular pressure will be measured using schiotz tonometer whereas optic nerve sheath diameter will be assessed using ultrasound in same patient at same intervals. This will give us both the values of intraocular pressure and optic nerve sheath diameter at same time which as per previous studies increases and are statistically significant. After compilation of results it will be analyzed that whether both values increases in a correlated manner or not which will give us our results that whether increase of one value can tell the increase of other value.

    9 months

Study Arms (1)

changes in eye

OTHER

Changes in both intraocular pressure and optic nerve sheath diameter will be correlated in robotic surgeries to find out any statistical relation existing between two.

Procedure: Schiotz tonometer for Intraocular Pressure

Interventions

Both Values will be corelated

Also known as: Ultrasound for Optic nerve sheath diameter
changes in eye

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • robotic surgeries
  • surgical duration upto 4 hours
  • american society of anaesthesiologists 1 to 3

You may not qualify if:

  • any history of opthalmic intervention
  • patient suffering from glaucoma
  • patients taking any diuretics for cardiac problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

MeSH Terms

Interventions

Intraocular PressureHigh-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ocular Physiological PhenomenaUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Nitesh Goel, MBBS,DA, DNB

    Rajiv Gandhi Cancer Institute & Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitesh Goel, MBBS,DA,DNB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Nitesh Goel, Consultant Anaesthesia

Study Record Dates

First Submitted

February 20, 2016

First Posted

March 3, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-02

Locations