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

Ketamine

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

Intervention / Treatment

  • TIVA (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 (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

Condition or Disease

  • Intraocular Pressure
  • Oncology

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 99 Years
    Enrollment: 100 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

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    Clinical Trial Dates

    Start date: Nov 10, 2020 ACTUAL
    Primary Completion: Jul 20, 2025 ESTIMATED
    Completion Date: Jul 20, 2026 ESTIMATED
    Study First Posted: Feb 21, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: May 26, 2023

    Sponsors / Collaborators

    Lead Sponsor: University of Florida
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Gainesville, Florida, USA

    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.

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 99
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

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    Primary Outcomes

    • quantify the degree of change in IOP in female patients undergoing robotic procedures for cancer

    More Details

    NCT Number: NCT04281017
    Other IDs: IRB202000034
    Study URL: https://clinicaltrials.gov/study/NCT04281017
    Last updated: Sep 29, 2023