Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Athens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Argyro Fassoulaki, University of Athens
ClinicalTrials.gov Identifier:
NCT01301261
First received: February 22, 2011
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention
Surgical Procedure, Unspecified
Drug: sugammadex
Drug: Sugammadex 4 mg/kg
Drug: Sugammadex 16mg/kg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Entropy [ Time Frame: every three minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemodynamics [ Time Frame: every three minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 22, 2011
Last Updated: June 18, 2012
Health Authority: Greece: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 21, 2014