Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

NCT ID: NCT01574950

Last Updated: 2015-10-26

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

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-06-30

Brief Summary

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Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Detailed Description

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Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. We hypothesize that impaired cerebral autoregulation may be a possible mechanism for postoperative delirium. We will measure intraoperative cerebral autoregulation and assess the relationship with postoperative dleirium. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. ≥ 70 years old,
2. Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery \> 2 levels

Exclusion Criteria

1. MMSE \< 15
2. Delirium at baseline
3. Inability to speak and understand English
4. Severe hearing impairment, resulting in inability to converse.
5. Planned use of intraoperative ketamine
6. Planned use of intraoperative remifentanil, except for airway management pre-incision.
7. Arterial catheter not planned to be inserted
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Charles Brown, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Brown, MD

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

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The Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00051796

Identifier Type: -

Identifier Source: org_study_id

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