Quantitative Rise in Intraocular Pressure in Steep Trende... | NCT02646033

Studies
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

NCT02646033

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Status

Completed

Last Update Posted

Mar 17, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Intraocular Pressure

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Sep 2018Actual

Completion Date

Apr 2019Actual

First Submitted Date

Jan 4, 2016

First Submission Date that Met QC Criteria

Jan 4, 2016

First Posted Date

Jan 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2020

Last Update Posted Date

Mar 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Nitesh Goel, Doctor, Consultant Anaesthesia, Rajiv Gandhi Cancer Institute & Research Center, IndiaPrincipal Investigator

Lead Sponsor

Rajiv Gandhi Cancer Institute & Research Center, IndiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
robotic surgery		all those patients aged 40 - 60 years undergoing robotic surgeries, who does not have any ophthalmic complains.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular pressure	change in pressure with the position during surgery	7-8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients undergoing robotic surgeries in steep trendelenburg position

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nitesh Goel, MBBS,DA, DNB	Rajiv Gandhi Cancer Institute & Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rajiv Gandhi Cancer Institute & Research Centre		New Delhi	National Capital Territory of Delhi	110085	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided