RecruitingPhase 4NCT04281017

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


Sponsor

University of Florida

Enrollment

40 participants

Start Date

Nov 10, 2020

Study Type

INTERVENTIONAL

Conditions

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 study showed decrease in Intraocular Pressure (IOP) in robotic case in steep Trendelenburg with IV anesthetics (TIVA). We want to quantify the degree of change in Intraocular Pressure (IOP) in female patients undergoing robotic procedures for cancer. We want to detect the difference in increase of pressure with total IV anesthesia versus conventional balanced anesthesia


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how the positioning used during robotic gynecologic (GYN) oncology surgery — and the choice of anesthesia — affects pressure inside the eye (intraocular pressure, or IOP). During these surgeries, patients are positioned steeply tilted (Trendelenburg position) for long periods, which can increase eye pressure. Elevated IOP could potentially harm vision in some patients, so this study aims to better understand and manage this risk. You may be eligible if: - You are a woman at least 18 years old - You are scheduled for robotic surgery for gynecological cancer or high suspicion of cancer - You have been cleared for surgery by the pre-anesthesia clinic - You are willing to comply with all study-related procedures You may NOT be eligible if: - You have a known condition of increased intraocular pressure - You have had prior eye surgery within the past month - You have an eye condition where an ophthalmologist has determined that measuring intraocular pressure is not safe - You have previously been diagnosed with or treated for increased eye pressure Talk to your gynecologic oncologist about this study if you are scheduled for robotic GYN surgery and are interested in contributing to research on surgical safety.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTIVA

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg)

DRUGBalanced anesthesia

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT04281017


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