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Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

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ClinicalTrials.gov Identifier: NCT01301261
Recruitment Status : Unknown
Verified June 2012 by Argyro Fassoulaki, University of Athens.
Recruitment status was:  Recruiting
First Posted : February 23, 2011
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Surgical Procedure, Unspecified Drug: sugammadex Drug: Sugammadex 4 mg/kg Drug: Sugammadex 16mg/kg

Detailed Description:

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


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker
Study Start Date : December 2010
Estimated Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: sugammadex 2 mg/kg
2 mg/kg of sugammadex are given when a response of two counts of train of four are present
Drug: sugammadex
Sugammadex 2 mg/kg when a two count of train of four appears
Active Comparator: 4 mg/kg of sugammadex
4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears
Drug: Sugammadex 4 mg/kg
Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears
Active Comparator: Sugammadex 16 mg/kg
Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium
Drug: Sugammadex 16mg/kg
Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium


Outcome Measures

Primary Outcome Measures :
  1. Entropy [ Time Frame: every three minutes ]

Secondary Outcome Measures :
  1. hemodynamics [ Time Frame: every three minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients hypertensive
  • treated with antihypertensive drugs
Contacts and Locations

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): NCT01301261


Contacts
Contact: Argyro Fassoulaki, MD, PhD, DEAA +30210 9024530 fassoula@aretaieio.uoa.gr
Contact: Konstantinos Chondrogiannis, MD

Locations
Greece
Department of Anesthesiology, Aretaieio Hospital Recruiting
Athens, Greece, 11528
Contact: Argyro Fassoulaki, MD, PhD, DEAA         
Contact: Konstantinos Chondrogiannis         
Sponsors and Collaborators
University of Athens
More Information

Responsible Party: Argyro Fassoulaki, MD, PhD, DEAA, University of Athens
ClinicalTrials.gov Identifier: NCT01301261     History of Changes
Other Study ID Numbers: Σ-150/03-08-10
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Argyro Fassoulaki, University of Athens:
Sugammadex
entropy
bispectral index
blood pressure
heart rate
oxygenation
end-tidal CO2
hemodynamics
general anesthesia

Additional relevant MeSH terms:
Cisatracurium
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs