Intraocular Pressure During Spine Surgery - Full Text View

Sponsor:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00593359

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

Resource links provided by NLM:

Drug Information available for: Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

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 ]

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

Study Population

Patients undergoing spinal surgery in the prone position for at least 5 hours.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593359

Locations

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Study Chair:

Daniel I Sessler, MD

The Cleveland Clinic

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 February 09, 2012