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

Not Applicable

Completed

• Conditions: ICU Patients
• Interventions: Device: BIS

• Registration Number: NCT00714974
• Lead Sponsor: University of Utah

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2003-02
• Study Completion: 2007-10
• Status Verified: 2008-07
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Last Update Submitted: 2008-07-08
• Study First Posted: 2008-07-14
• Last Update Posted: 2008-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria

• Unable to be consented

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	BIS	Sedation based on BIS value, oer treating physician discretion.

Primary Outcome Measures

Name	Time	Method
Amount of sedation required.	During period of neuromuscular blockade use in ICU

Secondary Outcome Measures

Name	Time	Method
Time requiring neuromuscular blockade and mechanical ventilation.	Time in ICU