Intraocular Pressure During Spine Surgery

February 19, 2016 updated by: The Cleveland Clinic

The Effect of Lactated Ringer's Solution Versus Albumin and the Alpha-2 Agonist Brimonidine Versus Placebo on Intraocular Pressure During Prone Spine Surgery

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

Study Overview

Status

Completed

Conditions

Intraocular Pressure

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing spinal surgery in the prone position for at least 5 hours.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
A Lactated Ringer's replacement for blood loss and placebo eye drops
B Lactated Ringer's replacement for blood loss and brimonidine eye drops
C Albumin replacement for blood loss and placebo eye drops;
D Albumin replacement for blood loss and brimonidine eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome will be the maximum intraocular pressure at any time during surgery. Time Frame: 15 days post surgery	15 days post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 15 days post surgery	15 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)