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

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.

Study Overview

• Status: Completed
• Conditions: ICU Patients
• Intervention / Treatment: Device: BIS

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria:

• Unable to be consented

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Standard of care
Experimental: 2; Sedation based on BIS value, oer treating physician discretion.	Device: BIS; Sedation dosing based on BIS value, oer treating physician discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of sedation required.	During period of neuromuscular blockade use in ICU

Secondary Outcome Measures

Outcome Measure	Time Frame
Time requiring neuromuscular blockade and mechanical ventilation.	Time in ICU

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion (Actual): February 1, 2003
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: July 8, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): July 14, 2008
• Last Update Submitted That Met QC Criteria: July 8, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Neuromuscular blocking agents; Bispectral analysis
• Other Study ID Numbers: UU7643