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

NCT00714974 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2008-07-14

No results posted yet for this study

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.

Conditions

  • ICU Patients

Interventions

DEVICE

BIS

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-02-29
Primary Completion
2003-02-28
Completion
2007-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00714974 on ClinicalTrials.gov