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Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice (SEVOPROTECTION)

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ClinicalTrials.gov Identifier: NCT01282203
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : January 7, 2013
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Anesthesia, General

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adults Requiring Anesthesia for Surgery Adult patients requiring general anesthesia for surgery

Participant Flow:   Overall Study
    Adults Requiring Anesthesia for Surgery
STARTED   1122 
COMPLETED   1121 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Adults Requiring Anesthesia for Surgery Adult patients requiring general anesthesia for surgery

Baseline Measures
   Adults Requiring Anesthesia for Surgery 
Overall Participants Analyzed 
[Units: Participants]
 1122 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.1  (9.0) 
Gender 
[Units: Participants]
 
Female   619 
Male   503 


  Outcome Measures

1.  Primary:   Time to Loss of Consciousness of Patients Administered Anesthesia   [ Time Frame: Up to 10 minutes ]

2.  Primary:   Time to Awakening of Patients   [ Time Frame: Every minute after anesthesia was stopped until the patient responded to a verbal command. ]

3.  Primary:   Time to Extubation of Patients   [ Time Frame: Every minute after anesthesia was stopped until extubation occurred ]

4.  Primary:   Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia   [ Time Frame: Day 1 ]

5.  Primary:   Patients' Overall Impression of Anesthesia With Sevorane   [ Time Frame: Day 1 ]

6.  Secondary:   Systolic Blood Pressure   [ Time Frame: Before starting anesthesia to one hour after the surgery ]

7.  Secondary:   Diastolic Blood Pressure   [ Time Frame: Before starting anesthesia to one hour after the surgery ]

8.  Secondary:   Mean Arterial Pressure   [ Time Frame: Before starting anesthesia to one hour after the surgery ]

9.  Secondary:   Heart Rate   [ Time Frame: Before starting anesthesia to one hour after the surgery ]

10.  Secondary:   Presence of Deviations in Electrocardiogram Assessments During Anesthesia   [ Time Frame: During induction and maintenance of anesthesia ]

11.  Secondary:   Cardiac Troponin (if Available)   [ Time Frame: Within 24 hours after anesthesia ]

12.  Secondary:   Creatine Kinase Myocardial Isoenzyme (if Available)   [ Time Frame: Within 24 hours after anesthesia ]

13.  Secondary:   Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia   [ Time Frame: Before starting anesthesia to one hour after the surgery ]

14.  Secondary:   Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening   [ Time Frame: Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command ]

15.  Secondary:   Anesthesiologists' Duration of Clinical Experience With Anesthesia   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Troponin T and CK-MB values were not collected in the study, therefore no conclusions can be made regarding the influence of volatile induction and maintenance anesthesia with Sevorane on myocardial ischemia markers.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
phone: 1-800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01282203     History of Changes
Other Study ID Numbers: P12-638
First Submitted: January 21, 2011
First Posted: January 24, 2011
Results First Submitted: November 30, 2012
Results First Posted: January 7, 2013
Last Update Posted: March 4, 2013