Sugammadex and Brain Waves

Tampere University Hospital30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anaesthesia

Interventions

SugammadexDRUG

Sugammadex 200 mg iv, single dose, bolus.

Neostigmine and glycopyrrolateDRUG

Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Tampere University Hospital

Tampere, Finland

Outcomes

Primary Outcomes

The behaviour of depth of anaesthesia indexes (BIS,SE,RE)

Time frame: 30 minutes

Secondary Outcomes

The behaviour of electroencephalography

Time frame: 30 minutes

Data from ClinicalTrials.gov

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