Intraocular Pressure During Spine Surgery
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Purpose
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
| Condition |
|---|
|
Intraocular Pressure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing spinal surgery in the prone position for at least 5 hours.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ehab Farag, MD, Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT00593359 History of Changes |
| Other Study ID Numbers: | 07-571 |
| Study First Received: | January 2, 2008 |
| Last Updated: | March 16, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Outcomes Research Consortium:
|
Spinal surgery Prone spinal surgery |
Additional relevant MeSH terms:
|
Brimonidine Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013