NCT00714974

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2000

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

3 years

First QC Date

July 8, 2008

Last Update Submit

July 8, 2008

Conditions

ICU Patients

Keywords

Neuromuscular blocking agentsBispectral analysis

Outcome Measures

Primary Outcomes (1)

  • Amount of sedation required.

    During period of neuromuscular blockade use in ICU

Secondary Outcomes (1)

  • Time requiring neuromuscular blockade and mechanical ventilation.

    Time in ICU

Study Arms (2)

1

NO INTERVENTION

Standard of care

2

EXPERIMENTAL

Sedation based on BIS value, oer treating physician discretion.

Device: BIS

Interventions

BISDEVICE

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consented ICU patient, receiving neuromuscular blocking agents.

You may not qualify if:

  • Unable to be consented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

February 1, 2000

Primary Completion

February 1, 2003

Study Completion

October 1, 2007

Last Updated

July 14, 2008

Record last verified: 2008-07