Sugammadex and Brain Waves

NCT ID: NCT01142648

Last Updated: 2010-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Sugammadex

Sugammadex 200 mg iv, single dose, bolus.

Intervention Type DRUG

Neostigmine and glycopyrrolate

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

Intervention Type DRUG

Other Intervention Names

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Bridion Glycostigmin.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tampere University Hospital

Principal Investigators

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Arvi Yli-Hankala, MD

Role: STUDY_CHAIR

Tampere University Hospital

Arvi Yli-Hankala, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2009-010916-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R09041M

Identifier Type: -

Identifier Source: org_study_id

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