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

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00714974
First received: July 8, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention
ICU Patients
Device: BIS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Amount of sedation required. [ Time Frame: During period of neuromuscular blockade use in ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time requiring neuromuscular blockade and mechanical ventilation. [ Time Frame: Time in ICU ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: February 2000
Study Completion Date: October 2007
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion Criteria:

  • Unable to be consented
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Edward J. Kimball MD, University of Utah
ClinicalTrials.gov Identifier: NCT00714974     History of Changes
Other Study ID Numbers: UU7643
Study First Received: July 8, 2008
Last Updated: July 8, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 19, 2014