NCT01142648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

11 months

First QC Date

June 10, 2010

Last Update Submit

June 10, 2010

Conditions

Anaesthesia

Keywords

ElectroencephalogramElectromyogramEntropy IndexBispectral IndexReversal of neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

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

    30 minutes

Secondary Outcomes (1)

  • The behaviour of electroencephalography

    30 minutes

Interventions

SugammadexDRUG

Sugammadex 200 mg iv, single dose, bolus.

Also known as: Bridion
Neostigmine and glycopyrrolateDRUG

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

Also known as: Glycostigmin.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Interventions

SugammadexNeostigmineGlycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Arvi Yli-Hankala, MD

    Tampere University Hospital

    STUDY CHAIR

  • Arvi Yli-Hankala, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

FI(1)