A Prospective, Randomized, Blinded Study of BIS Analysis in ICU Patients Requiring Neuromuscular Blocking Agents
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|ClinicalTrials.gov Identifier: NCT00714974|
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: 1
Standard of care
Sedation based on BIS value, oer treating physician discretion.
Sedation dosing based on BIS value, oer treating physician discretion.
- Amount of sedation required. [ Time Frame: During period of neuromuscular blockade use in ICU ]
- Time requiring neuromuscular blockade and mechanical ventilation. [ Time Frame: Time in ICU ]