Sugammadex and Brain Waves

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Anaesthesia

Treatments: Drug: Neostigmine and glycopyrrolate; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT01142648

R09041M

2009-010916-14 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind