Status:

ACTIVE_NOT_RECRUITING

Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients

Lead Sponsor:

University of Florida

Conditions:

Intraocular Pressure

Oncology

Eligibility:

FEMALE

18-99 years

Phase:

PHASE4

Brief Summary

Steep Trendelenburg positioning and insufflation of the abdominal cavity have shown to increase intra ocular pressure. Different anesthetic techniques can alter intra ocular pressure and a small pilot...

Detailed Description

During the day of surgery, the anesthesiologist trained by an ophthalmologist, will measure each eye's Intraocular Pressure (IOP) using a tonometer for both the Trendelenburg with IV anesthetics (TIVA...

Eligibility Criteria

Inclusion

  • Females ≥ eighteen years of age
  • Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
  • Subjects must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer)
  • Subjects must be cleared for surgery by the pre-anesthesia clinic
  • All robotic GYN cancer patients 18 years of age and older with any preexisting medical conditions that are deemed ready for surgery by the pre anesthesia clinic

Exclusion

  • Known increased intraocular pressure, prior eye surgery within a month, eye conditions where the ophthalmologist would not allow an intra ocular pressure measurement
  • Subjects with a previous treatment of diagnosis of increased intraocular pressure
  • Subjects who have undergone eye surgery in the 30 days prior to consent
  • Subjects for whom an ophthalmologist has determined cannot undergo intraocular pressure measurement

Key Trial Info

Start Date :

November 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2025

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT04281017

Start Date

November 10 2020

End Date

November 1 2025

Last Update

June 10 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Florida

Gainesville, Florida, United States, 32610