Impact of anesthesia and positioning on eye pressure in robotic gynecologic surgery
Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients
This study tests how different types of anesthesia and body positions during robotic surgery for gynecological cancer affect eye pressure in women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04281017 on ClinicalTrials.gov |
What this trial studies
This study investigates how different anesthetic techniques and patient positioning affect intraocular pressure (IOP) in female patients undergoing robotic surgery for gynecological cancer. Specifically, it compares total intravenous anesthesia (TIVA) with conventional balanced anesthesia during steep Trendelenburg positioning. IOP will be measured at multiple time points throughout the surgical procedure to assess changes and determine the safest anesthetic approach. The study aims to provide insights that could enhance patient safety and outcomes during robotic gynecologic surgeries.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 and older who are scheduled for robotic surgery due to gynecological cancer or high suspicion of cancer.
Not a fit: Patients with known increased intraocular pressure, recent eye surgery, or specific eye conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of intraocular pressure during robotic surgeries, enhancing patient safety and reducing the risk of ocular complications.
How similar studies have performed: While this approach has shown promise in pilot studies, it is still relatively novel and further investigation is needed to confirm its efficacy.
Eligibility criteria
Show full inclusion / exclusion 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must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer) * Subjects must be cleared for surgery by the pre-anesthesia clinic * All robotic GYN cancer patients 18 years of age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
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sonia Mehta, MD — University of Florida
- Study coordinator: Sonia Mehta, MD
- Email: sdeshmukh@anest.ufl.edu
- Phone: 352-273-7094
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.