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NCT02646033 Clinical Trial

Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

Intraocular Pressure Clinical Trial

Official title:
Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02646033
Other study ID # RajivGCIRC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date April 2019

Study information
Verified date March 2020
Source Rajiv Gandhi Cancer Institute & Research Center, India
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Rajiv Gandhi Cancer Institute & Research Centre New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure change in pressure with the position during surgery 7-8 months
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