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OpenTrials
Completed

NCT Number: NCT00593359

Intraocular Pressure During Spine Surgery

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

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Key information

Conditions

Intraocular Pressure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The primary outcome will be the maximum intraocular pressure at any time during surgery.

    Time frame: 15 days post surgery

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 15, 2008
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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