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Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position

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ClinicalTrials.gov Identifier: NCT02646033
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Nitesh Goel, Rajiv Gandhi Cancer Institute & Research Center, India

Study Description
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Brief Summary:
This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : April 2019
Groups and Cohorts
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Group/Cohort
robotic surgery
all those patients aged 40 - 60 years undergoing robotic surgeries, who does not have any ophthalmic complains.


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 7-8 months ]
    change in pressure with the position during surgery


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing robotic surgeries in steep trendelenburg position
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646033


Locations
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India
Rajiv Gandhi Cancer Institute & Research Centre
New Delhi, Delhi, India, 110085
Sponsors and Collaborators
Rajiv Gandhi Cancer Institute & Research Center, India
Investigators
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Principal Investigator: Nitesh Goel, MBBS,DA, DNB Rajiv Gandhi Cancer Institute & Research Centre
More Information
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Responsible Party: Dr. Nitesh Goel, Doctor, Consultant Anaesthesia, Rajiv Gandhi Cancer Institute & Research Center, India
ClinicalTrials.gov Identifier: NCT02646033    
Other Study ID Numbers: RajivGCIRC
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Nitesh Goel, Rajiv Gandhi Cancer Institute & Research Center, India:
Intraocular Pressure, Trendelenburg position