Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-02-28

Brief Summary

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A rare but terrible complication of vision loss has been known to occur after surgery, including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is one of the reasons for this rare vision loss. It has been shown that the prone position can increase the IOP, and that tilting the patient with the head down can also increase IOP. The investigators will be measuring IOP before, during, and after a posterior spine surgery to see if the investigators can influence the intraocular pressure with elevated head position change. Two groups will be studied: one group of patients will receive standard care with the head in neutral position, while the other group will have the head slightly elevated 10 degrees during prone spine surgery.

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Detailed Description

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It has been reported that postoperative vision loss after lumbar surgery is increasing. It is an uncommon but devastating complication. One of the risk factors that has been reported is increased intraocular pressure (IOP), which may decrease perfusion pressure to the optic nerve. Intraocular pressure in anesthetized, prone spine patients has been studied with the head in neutral position. The prone position and duration of the procedure did increase the IOP. Our hypothesis is that adjusting the position of the head in space will alter the intraocular pressure, with an extended position decreasing IOP. This study is a, randomized, controlled design: neutral head position (standard care) or extended head position (intervention group). Patients who qualify for spinal fusion surgery and meet the inclusion criteria will be randomized to either the neutral (standard practice) or the intervention group.Randomization of patients will be computer generated.

Conditions

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Raised Ocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Head raised 10 degrees

Head raised 10 degrees from neutral position using Gardner Wells tongs

Group Type EXPERIMENTAL

Head raised 10 degrees

Intervention Type PROCEDURE

Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.

Head in neutral position

Group Type ACTIVE_COMPARATOR

Head in neutral position

Intervention Type PROCEDURE

Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.

Interventions

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Head raised 10 degrees

Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.

Intervention Type PROCEDURE

Head in neutral position

Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective lumbar spinal fusion surgery; ages 18-80

Exclusion Criteria

* Less than 18 years of age
* Glaucoma, previous eye surgery, eye injury, or eye trauma, cervical myelopathy, prior cervical spine surgery, current neoplasm, patients who have neck pain with 10 degrees active extension.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes