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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00714974
Enrollment
56
Registered
2008-07-14
Start date
2000-02-29
Completion date
2007-10-31
Last updated
2008-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU Patients

Keywords

Neuromuscular blocking agents, Bispectral analysis

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.

Interventions

DEVICEBIS

Sedation dosing based on BIS value, oer treating physician discretion.

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consented ICU patient, receiving neuromuscular blocking agents.

Exclusion criteria

* Unable to be consented

Design outcomes

Primary

MeasureTime frame
Amount of sedation required.During period of neuromuscular blockade use in ICU

Secondary

MeasureTime frame
Time requiring neuromuscular blockade and mechanical ventilation.Time in ICU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026