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OpenTrials
Completed

NCT Number: NCT01142648

Sugammadex and Brain Waves

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.

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Key information

Conditions

Anaesthesia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Sugammadex 200 mg iv, single dose, bolus.

Other names: Bridion

Neostigmine and Glycopyrrolate

Drug

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

Other names: Glycostigmin.

Primary outcomes

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

    Time frame: 30 minutes

Secondary outcomes

  1. The behaviour of electroencephalography

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

The Effect of Sugammadex of EEG-derived Index Values

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2010
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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