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

NCT04281017 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: IRB202000034OCR33027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Intraocular Pressure; Oncology

Keywords

robotic gynecologic surgery

Outcome Measures

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

  Day of Surgery

Study Arms (2)

TIVA anesthesia

EXPERIMENTAL

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.

Drug: TIVA

Balanced anesthesia

ACTIVE COMPARATOR

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.

Drug: Balanced anesthesia

Interventions

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)

TIVA anesthesia

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

Balanced anesthesia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: GYN cases only done in female subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Balanced Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sonia Mehta, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Mehta, MD

CONTACT

352-273-7094; sdeshmukh@anest.ufl.edu

Anna Woods

CONTACT

352-294-8345; awoods@anest.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 21, 2020
• Study Start: November 10, 2020
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)