Electromyographic (EMG) on the Anaesthesia Monitor

Anaesthesia Clinical Trial

Official title:

The Appearance of Electromyography on the Anaesthesia Monitor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142635
• Other study ID #: R08197M
• Secondary ID: 2008-008129-31
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2010
• Last updated: June 10, 2010
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.

Description:

Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• females giving informed consent

• age range 18-65 years

• elective surgery: gynaecological

• general anaesthesia

• ASA classification 1 or 2

Exclusion Criteria:

• pregnancy

• body mass index > 30

• disease affecting CNS

• overuse of alcohol

• drug abuse

• unability to understand, read or use Finnish language

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia

Intervention

Drug:
• Rocuronium bromide
Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose
• Rocuronium bromide
Rocuronium, iv, single dose, single bolus, 1.2 mg/kg

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The behaviour of biosignal on the anaesthesia monitor	The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor	30 minutes	No
Secondary	The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation	Intubation-associated changes in the numerical values of BIS, SE, RE	30 min	No