Intraocular Pressure During Spine Surgery

Completed

• Conditions: Intraocular Pressure

• Registration Number: NCT00593359
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:

Group A - Lactated Ringer's replacement for blood loss and placebo eye drops

Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops

Group C - Albumin replacement for blood loss and placebo eye drops

Group D - Albumin replacement for blood loss and brimonidine eye drops

Detailed Description

Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-15
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Spine surgery with instrumentation in prone position expected to last at least 5 hours;
• Anticipated blood loss ≥ 1L
• Age 18-80 years old;
• ASA physical status I-III.

Exclusion Criteria

• History of increased intraocular pressure or glaucoma;
• Diabetic retinopathy;
• Heart failure or serious left ventricular dysfunction;
• Abnormal preoperative fundus examination;
• Creatinine > 2 mg/dL;
• Patient refuses blood transfusion or albumin administration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the maximum intraocular pressure at any time during surgery.	15 days post surgery

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure as a function of surgical duration; Velocity of retrobulbar blood flow; Facial edema and or chemosis; Time to extubation; Duration of recovery Correlation between Dpp and FTc.	15 days post surgery

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States