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
Primary Outcome Measures:
- The primary outcome will be the maximum intraocular pressure at any time during surgery. [ Time Frame: 15 days post surgery ] [ Designated as safety issue: No ]
Secondary Outcome 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 ] [ Designated as safety issue: No ]
Biospecimen Description:
| Estimated Enrollment: |
60 |
| Study Start Date: |
December 2007 |
| Estimated Study Completion Date: |
December 2009 |
| Estimated Primary Completion Date: |
December 2009 (Final data collection date for primary outcome measure) |
|
A
Lactated Ringer's replacement for blood loss and placebo eye drops
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|
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
|
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.
Purpose
