Intraocular Pressure During Spine Surgery

Intraocular Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00593359
• Other study ID #: 07-571
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: February 19, 2016
• Start date: December 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intraocular Pressure

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the maximum intraocular pressure at any time during surgery.		15 days post surgery	No
Secondary	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	No