NCT04281017 Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients
| NCT ID | NCT04281017 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Intraocular Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-11-10 |
| Primary Completion | 2026-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2020-11-10 with a primary completion date of 2026-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer) * Subjects must be cleared for surgery by the pre-anesthesia clinic * All robotic GYN cancer patients 18 years of age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 Criteria: * 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
Contact & Investigator
Sonia Mehta, MD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT04281017 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Intraocular Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04281017 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04281017 currently recruiting?
Yes, NCT04281017 is actively recruiting participants. Contact the research team at sdeshmukh@anest.ufl.edu for enrollment information.
Where is the NCT04281017 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT04281017 clinical trial?
NCT04281017 is sponsored by University of Florida. The principal investigator is Sonia Mehta, MD at University of Florida. The trial plans to enroll 40 participants.