NCT02646033

Brief Summary

This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

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

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

January 4, 2016

Last Update Submit

March 13, 2020

Conditions

Intraocular Pressure

Keywords

Intraocular Pressure, Trendelenburg position

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    change in pressure with the position during surgery

    7-8 months

Study Arms (1)

robotic surgery

all those patients aged 40 - 60 years undergoing robotic surgeries, who does not have any ophthalmic complains.

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing robotic surgeries in steep trendelenburg position

You may qualify if:

  • American Society of Anaesthesiologists (ASA) status 1-3
  • without any ophthalmic complains or interventions

You may not qualify if:

  • lasix given during preoperative or intraoperative period
  • cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG)
  • pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded

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

Location

Study Officials

  • Nitesh Goel, MBBS,DA, DNB

    Rajiv Gandhi Cancer Institute & Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, Consultant Anaesthesia

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

April 1, 2019

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)