B-AWAKE - The effect of muscle relaxants on the performance of the Bispectral Index depth-of-anaesthesia monitoring device.

Observing the effect of muscle relaxants on the Bispectral Index depth-of-anaesthesia monitoring device (BIS) in awake healthy volunteers.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000587707

Enrollment

Registered

2013-05-24

Start date

2013-09-26

Completion date

2013-11-08

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The Bispectral Index system (BIS) is an electronic device used during anaesthesia to determine whether or not a patient is "awake". A previous study reported that when fully awake subjects were given the muscle relaxant suxamethonium, the BIS system incorrectly reported that they were anaesthetised. Our study will investigate the effect of the two muscle relaxant drugs suxamethonium, and rocuronium, in awake volunteers, to confirm whether or not the BIS system behaves in this manner.

Interventions

The response of the Bispectral Index device (BIS) will be observed following the administration of suxamethonium 1.5 mg/kg i.v., until the drug effect ceases. On a separate occasion, at least 2 weeks later, the same subject will repeat the experiment but with rocuronium 0.7mg/kg i.v., to be reversed with sugammadex 200mg i.v.

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

25 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

ASA 1 or 2 Previous uneventful anaesthesia

Exclusion criteria

Gastro-oesophageal reflux BMI > 30

Outcome results