Intraocular Pressure During Spine Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00593359

Enrollment

Registered

2008-01-15

Start date

2007-12-31

Completion date

2010-02-28

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Keywords

Spinal surgery, Prone spinal surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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.	15 days post surgery

Countries

United States

Outcome results