Official Title: “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 Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: December 2008

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.

Arms, Groups and Cohorts in this Clinical Trial

• : 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

Primary Measures

• The primary outcome will be the maximum intraocular pressure at any time during surgery.
  • Time Frame: 15 days post surgery
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Outcomes Research Consortium

Overall Clinical Trial Officials and Contacts

Daniel I Sessler, MD Study Chair Cleveland Clinic  

Overall Contact: Ehab Farag, MD 216-444-0224 farage@ccf.org

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00593359

Study ID Number: 07-571

ClinicalTrials.gov Identifier: NCT00593359

Health Authority: United States: Institutional Review Board