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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714974
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
ICU Patients Device: BIS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents
Study Start Date : February 2000
Actual Primary Completion Date : February 2003
Actual Study Completion Date : October 2007

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.

Primary Outcome Measures :
  1. Amount of sedation required. [ Time Frame: During period of neuromuscular blockade use in ICU ]

Secondary Outcome Measures :
  1. Time requiring neuromuscular blockade and mechanical ventilation. [ Time Frame: Time in ICU ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria:

  • Unable to be consented

Responsible Party: Edward J. Kimball MD, University of Utah Identifier: NCT00714974     History of Changes
Other Study ID Numbers: UU7643
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: July 14, 2008
Last Verified: July 2008

Keywords provided by University of Utah:
Neuromuscular blocking agents
Bispectral analysis

Additional relevant MeSH terms:
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs