NCT04281017

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

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) and propofol/fentanyl/rocuronium arms of the study. (The Tono-Pen XL Medtronic Solan, Jacksonville, FL) The Intraocular Pressure (IOP) for both eyes will be measured at seven time points: Time 1 induction after administration of sedative and local anesthesia in the eye. Both eyes of the patient will anesthetized using topical proparacaine hydrochloride ophthalmic solution 0.5%. Time 2 Post induction table 0 degrees Time 3 Supine after pneumoperitoneum with 14 mmHg pressure Time 4 After docking robot at correct Trendelenburg positioned measured by a level Time 5 After undocking and before moving supine Time 6 Supine and before extubation. If the intraocular pressure remains elevated above 19 mmHg will require a 7th measurement in PACU with HOB at 30 degrees and if the pressure still at or above 19 ophthalmology consult initiated. Time 7 if needed, see above If the patient has any increased reading at the end of the procedure, the same attending anesthesiologist in the post-operative recovery area prior to discharge will do a post op measurement. Any abnormal readings will prompt an ophthalmology consult and follow up with ophthalmology department.

Conditions

• Intraocular Pressure
• Oncology

Interventions

Type	Name	Description
DRUG	TIVA	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)
DRUG	Balanced 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

Timeline

• Start date: 2020-11-10
• Primary completion: 2026-06-18
• Completion: 2027-06-18
• First posted: 2020-02-21
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study