Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity of Florida
About this trial
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
This trial accepts healthy volunteersQualifiers
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must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer)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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
TIVA
DrugInduction 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)
Balanced anesthesia
DrugInduction 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: TIVA anesthesiaExperimental treatment 1 intervention
Group B: Balanced anesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quantify the degree of change in intra ocular pressure in female patients undergoing robotic procedures
quantify the degree of change in IOP in female patients undergoing robotic procedures for cancer
Time frame
Day of SurgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov