A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients

Corewell Health East4 enrolled

Overview

This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.

Eye pressure will be measured at protocol specified intervals.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Intraocular Pressure Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects undergoing prolonged procedures (scheduled \>3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy) 2. Morbidly obese subjects: BMI ≥ 35 kg/m2 3. Thin subjects: BMI ≤ 30 kg/m2 4. Age 18-70 5. ASA (American Society of Anesthesiologists) physical status classification I, II, or III Exclusion Criteria: 1. Known history of glaucoma 2. Note:if initial IOP is noted to be \>21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed. 3. Recent use of IOP lowering topical ophthalmic agents 4. Allergy to latex or proparacaine hydrochloride ophthalmic solution 5. Patients with active corneal epithelial defects or history of recurrent corneal erosion 6. Patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, Sturge-Weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology) 7. History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis) 8. Any eye surgery within prior 1 month 9. Known pregnancy 10. Cognitive impairment

Locations (1)

William Beaumont Hospital

Royal Oak, Michigan, United States

Outcomes

Primary Outcomes

To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.

Time frame: Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.

Secondary Outcomes

To determine rate of rise of IOP during steep Trendelenburg positioning

Time frame: The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.

To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.

Time frame: The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.

Data from ClinicalTrials.gov

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