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CompletedNCT01142648Updated Jun 11, 2010

Sugammadex and Brain Waves

A Phase 4 interventional study of Sugammadex and Neostigmine and glycopyrrolate in Anaesthesia, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-06-11.

Sponsored by Tampere University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anaesthesia

Keywords

  • Electroencephalogram
  • Electromyogram
  • Entropy Index
  • Bispectral Index
  • Reversal of neuromuscular blockade
03

In context

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • females giving informed consent
  • age range 18-65 years
  • elective surgery: gynaecological
  • general anaesthesia
  • ASA classification 1 or 2

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • body mass index > 30
  • disease affecting CNS
  • overuse of alcohol
  • drug abuse
  • unability to understand, read or use Finnish language
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Interventions

  • DrugSugammadex

    Sugammadex 200 mg iv, single dose, bolus.

    Also known as: Bridion

  • DrugNeostigmine and glycopyrrolate

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

    Also known as: Glycostigmin.

06

What researchers measure

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

07

Study locations

1 site
  • Tampere University Hospital
    Tampere, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01142648
Lead sponsor
Tampere University Hospital
First posted
Jun 11, 2010
Start date
Apr 2009
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Jun 11, 2010

Study contacts

Arvi Yli-Hankala, MD
study chair · Tampere University Hospital
Arvi Yli-Hankala, MD
principal investigator · Tampere University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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