- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01301261
Sugammadex: Effect on the Awareness Monitoring and Hemodynamics
The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Argyro Fassoulaki, MD, PhD, DEAA
- Phone Number: +30210 9024530
- Email: fassoula@aretaieio.uoa.gr
Study Contact Backup
- Name: Konstantinos Chondrogiannis, MD
Study Locations
-
-
-
Athens, Greece, 11528
- Recruiting
- Department of Anesthesiology, Aretaieio Hospital
-
Contact:
- Argyro Fassoulaki, MD, PhD, DEAA
-
Contact:
- Konstantinos Chondrogiannis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients ASA I-III scheduled for elective major surgery
- both sexes
Exclusion Criteria:
- patients hypertensive
- treated with antihypertensive drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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
|
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
|
Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Entropy
Time Frame: every three minutes
|
every three minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hemodynamics
Time Frame: every three minutes
|
every three minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Σ-150/03-08-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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