Clinical trial

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

Name

IRB202000034

Description

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

Trial arms

Trial start

2020-11-10

Estimated PCD

2025-07-20

Trial end

2026-07-20

Status

Recruiting

Phase

Early phase I

Treatment

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)

Arms:

TIVA anesthesia

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

Arms:

Balanced anesthesia

Size

100

Primary endpoint

Quantify the degree of change in intra ocular pressure in female patients undergoing robotic procedures

Day of Surgery

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must be planning to receive robotic surgery for gynecological cancer or high suspicion of cancer (these subject will be withdrawn if it his proven they don't have cancer) * Subjects must be cleared for surgery by the pre-anesthesia clinic * All robotic GYN cancer patients 18 years of age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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-05-30

1 organization

2 products

2 indications

Organization

University of Florida

Product

Indication

Indication

Product