Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

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

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110085
      • Rajiv Gandhi Cancer Institute & Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing robotic surgeries in steep trendelenburg position

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Investigators: Principal Investigator: Nitesh Goel, MBBS,DA, DNB, Rajiv Gandhi Cancer Institute & Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Intraocular Pressure, Trendelenburg position
• Other Study ID Numbers: RajivGCIRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO