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

NCT ID: NCT04281017

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2027-06-18

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TIVA 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) to limit any discomfort caused by the propofol injection. After endotracheal intubation, intravenous infusion of propofol, lidocaine, ketamine or narcotic as deemed appropriate by anesthesiologist. There will be no inhalation anesthetic used. Ventilation with oxygen and air mixture (50%/50%) and titrated to keep the mean arterial pressure within 20% of its preinduction value. Muscle relaxation maintain using Aliquots of rocuronium to 0 to 1 train-of-4 twitch response of adductor pollicis. During surgery, mechanical ventilation using pressure-controlled mode (peak inspiratory pressure 30 cm H2O). We aim for Tidal volume of 5-7 ml/Kg of ideal body weight with a positive end-expiratory pressure of 5 cm H2O, and a respiratory rate to maintain end-tidal carbon dioxide between 30 to 40 mm Hg.

Group Type: EXPERIMENTAL

TIVA

Intervention Type: DRUG

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)

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) to limit any discomfort caused by the propofol injection. After endotracheal intubation, the depth of anesthesia will be maintained at a minimum alveolar concentration of 1 to 1.25 using isoflurane in oxygen and air mixture (50%/50%) and titrated to keep the mean arterial pressure within 20% of its preinduction value. Muscle relaxation maintain using Aliquots of rocuronium to 0 to 1 train-of-4 twitch response of adductor pollicis. During the surgery, subjects will be mechanically ventilated using pressure-controlled mode (peak inspiratory pressure 30 cm H2O). We aim for Tidal volume of 5-7 ml/Kg of ideal body weight with a positive end-expiratory pressure of 5 cm H2O, and a respiratory rate to maintain end-tidal carbon dioxide between 30 to 40 mm Hg.

Group Type: ACTIVE_COMPARATOR

Balanced anesthesia

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sonia Mehta, MD

Role: CONTACT

sdeshmukh@anest.ufl.edu

352-273-7094

Anna Woods

Role: CONTACT

awoods@anest.ufl.edu

352-294-8345

Facility Contacts

Sonia Mehta, MD

Role: primary

sdeshmukh@anest.ufl.edu

352-273-7094

Other Identifiers

OCR33027

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202000034

Identifier Type: -

Identifier Source: org_study_id