Sugammadex and Brain Waves

Phase 4

Completed

• Conditions: Anaesthesia

• Registration Number: NCT01142648
• Lead Sponsor: Tampere University Hospital

Brief Summary

According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.

Detailed Description

Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Last Update Submitted: 2010-06-10
• Study First Posted: 2010-06-11
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The behaviour of depth of anaesthesia indexes (BIS,SE,RE)	30 minutes

Secondary Outcome Measures

Name	Time	Method
The behaviour of electroencephalography	30 minutes

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland