Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

NCT ID: NCT01301261

Last Updated: 2012-06-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.

Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.

Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

Conditions

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Surgical Procedure, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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sugammadex 2 mg/kg

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

Group Type ACTIVE_COMPARATOR

sugammadex

Intervention Type DRUG

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

4 mg/kg of sugammadex

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

Group Type ACTIVE_COMPARATOR

Sugammadex 4 mg/kg

Intervention Type DRUG

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

Sugammadex 16 mg/kg

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

Group Type ACTIVE_COMPARATOR

Sugammadex 16mg/kg

Intervention Type DRUG

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

Interventions

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sugammadex

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

Intervention Type DRUG

Sugammadex 4 mg/kg

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

Intervention Type DRUG

Sugammadex 16mg/kg

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients hypertensive
* treated with antihypertensive drugs
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Argyro Fassoulaki

MD, PhD, DEAA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology, Aretaieio Hospital

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Argyro Fassoulaki, MD, PhD, DEAA

Role: CONTACT

+30210 9024530

Konstantinos Chondrogiannis, MD

Role: CONTACT

Facility Contacts

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Argyro Fassoulaki, MD, PhD, DEAA

Role: primary

Konstantinos Chondrogiannis

Role: backup

Other Identifiers

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Σ-150/03-08-10

Identifier Type: -

Identifier Source: org_study_id

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