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Trial record 60 of 186 for:    GLYCOPYRROLATE

Sugammadex and Brain Waves

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ClinicalTrials.gov Identifier: NCT01142648
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : June 11, 2010
Sponsor:
Information provided by:
Tampere University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Anaesthesia Drug: Sugammadex Drug: Neostigmine and glycopyrrolate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sugammadex of EEG-derived Index Values
Study Start Date : April 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Intervention Details:
  • Drug: Sugammadex
    Sugammadex 200 mg iv, single dose, bolus.
    Other Name: Bridion
  • Drug: Neostigmine and glycopyrrolate
    Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline
    Other Name: Glycostigmin.


Primary Outcome Measures :
  1. The behaviour of depth of anaesthesia indexes (BIS,SE,RE) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. The behaviour of electroencephalography [ Time Frame: 30 minutes ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142648


Locations
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Finland
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Study Chair: Arvi Yli-Hankala, MD Tampere University Hospital
Principal Investigator: Arvi Yli-Hankala, MD Tampere University Hospital

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Responsible Party: Arvi Yli-Hankala/Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01142648     History of Changes
Other Study ID Numbers: R09041M
2009-010916-14 ( EudraCT Number )
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Keywords provided by Tampere University Hospital:
Electroencephalogram
Electromyogram
Entropy Index
Bispectral Index
Reversal of neuromuscular blockade
Additional relevant MeSH terms:
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Glycopyrrolate
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists