Intraocular Pressure During Spine Surgery

NCT ID: NCT00593359

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Intraocular Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Lactated Ringer's replacement for blood loss and placebo eye drops

No interventions assigned to this group

B

Lactated Ringer's replacement for blood loss and brimonidine eye drops

No interventions assigned to this group

C

Albumin replacement for blood loss and placebo eye drops;

No interventions assigned to this group

D

Albumin replacement for blood loss and brimonidine eye drops

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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07-571

Identifier Type: -

Identifier Source: org_study_id

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