NCT00593359

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

January 2, 2008

Last Update Submit

February 19, 2016

Conditions

Intraocular Pressure

Keywords

Spinal surgeryProne spinal surgery

Outcome Measures

Primary Outcomes (1)

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

    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.

    15 days post surgery

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Daniel I Sessler, MD

    The Cleveland Clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 15, 2008

Study Start

December 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)