A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

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

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2007-10-31

Brief Summary

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This is a prospective, randomized, blinded study in which patients will be enrolled into either treated(BIS group) or untreated (non-BIS) group employing bispectral analysis to measure the level of sedation/analgesia in patients receiving neuromuscular blocking agents.

To collect pertinent data on critically ill patients while they are receiving NMBA's. In particular to correlate sedation/analgesic medication needs between a group whose medication use is determined by the values obtained by bispectral analysis to a group who will have medications delivered by the standard of care presently used in the intensive care unit in which they are being treated.

To document that patients who are monitored with bispectral analysis are able to achieve an appropriate level of consciousness in a shorter time and require less manipulation and amounts of sedative or analgesic medications than those who are not monitored.

Detailed Description

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This is a prospective, randomized and blinded study being done in order to help evaluate the level of consciousness with bispectral analysis (BIS) in ICU patients who are pharmacologically paralyzed with NMBAs (neuromuscular blockade agents) and to assess such things as the amount of time required to achieve the appropriate level of sedation/analgesia. Data will be collected and evaluated via this FDA approved equipment. The intent of this project is to evaluate this technology in those who are requiring "anesthesia" like states (use of NMBAs) for prolonged periods in the critically ill patient population.

Conditions

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ICU Patients

Keywords

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Neuromuscular blocking agents Bispectral analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Sedation based on BIS value, oer treating physician discretion.

Group Type EXPERIMENTAL

BIS

Intervention Type DEVICE

Sedation dosing based on BIS value, oer treating physician discretion.

Interventions

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BIS

Sedation dosing based on BIS value, oer treating physician discretion.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria

* Unable to be consented

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of Utah

Other Identifiers

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UU7643

Identifier Type: -

Identifier Source: org_study_id