Intraocular Pressure During Spine Surgery
Information source: Outcomes Research Consortium
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraocular Pressure
Phase: N/A
Status: Recruiting
Sponsored by: Outcomes Research Consortium Official(s) and/or principal investigator(s):
Daniel I Sessler, MD, Study Chair, Affiliation: Cleveland Clinic
Overall contact:
Ehab Farag, MD, Phone: 216-444-0224, Email: farage@ccf.org
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
Clinical Details
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
Study design: Cohort, Prospective
Primary outcome: The primary outcome will be the maximum intraocular pressure at any time during surgery.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Ehab Farag, MD, Phone: 216-444-0224, Email: farage@ccf.org
Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Crystal Franklin, Phone: 216-444-0225, Email: franklc@ccf.org
Ehab Farag, MD, Principal Investigator
Additional Information
Starting date: December 2007
Ending date: December 2009
Last updated: September 21, 2009
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