NCT01301261

Brief Summary

Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

2.2 years

First QC Date

February 22, 2011

Last Update Submit

June 18, 2012

Conditions

Surgical Procedure, Unspecified

Keywords

Sugammadexentropybispectral indexblood pressureheart rateoxygenationend-tidal CO2hemodynamicsgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Entropy

    every three minutes

Secondary Outcomes (1)

  • hemodynamics

    every three minutes

Study Arms (3)

sugammadex 2 mg/kg

ACTIVE COMPARATOR

2 mg/kg of sugammadex are given when a response of two counts of train of four are present

Drug: sugammadex

4 mg/kg of sugammadex

ACTIVE COMPARATOR

4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears

Drug: Sugammadex 4 mg/kg

Sugammadex 16 mg/kg

ACTIVE COMPARATOR

Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium

Drug: Sugammadex 16mg/kg

Interventions

sugammadexDRUG

Sugammadex 2 mg/kg when a two count of train of four appears

sugammadex 2 mg/kg
Sugammadex 4 mg/kgDRUG

Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears

4 mg/kg of sugammadex
Sugammadex 16mg/kgDRUG

Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium

Sugammadex 16 mg/kg

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients ASA I-III scheduled for elective major surgery
  • both sexes

You may not qualify if:

  • patients hypertensive
  • treated with antihypertensive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Aretaieio Hospital

Athens, 11528, Greece

RECRUITING

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Central Study Contacts

Argyro Fassoulaki, MD, PhD, DEAA

CONTACT

+30210 9024530fassoula@aretaieio.uoa.gr

Konstantinos Chondrogiannis, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, DEAA

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

December 1, 2010

Primary Completion

February 1, 2013

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

GR(1)