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Intraocular Pressure During Spine Surgery

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Completed

Conditions

Intraocular Pressure

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

A
Description:
Lactated Ringer's replacement for blood loss and placebo eye drops
B
Description:
Lactated Ringer's replacement for blood loss and brimonidine eye drops
C
Description:
Albumin replacement for blood loss and placebo eye drops;
D
Description:
Albumin replacement for blood loss and brimonidine eye drops

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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