Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia

This study has been completed.
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01191476
First received: August 27, 2010
Last updated: May 31, 2012
Last verified: May 2012
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Elective Laparoscopic Surgery
Interventions: Drug: Sevoflurane Inhalational Induction and Maintenance
Drug: Propofol Target Controlled Infusion for Induction and Maintenance
Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects between the ages of 18 and 65 were recruited from 4 hospitals in 4 cities in China. They were required to have elective laparoscopic, in-patient surgery with a predicted anesthetic duration between 1 to 3 hours. Subjects with ASA physical status I or II were enrolled and were to have had the ability to provide informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was a prospective, randomized (1:1:1), open-label, multi-center study comparing the cost of inhalational anesthesia with sevoflurane to intravenous (IV) anesthesia with propofol, or propofol for induction and sevoflurane for maintenance of anesthesia. The full analysis set was used for determination of all primary and secondary endpoints.

Reporting Groups
  Description
Sevoflurane Inhalational induction and maintenance anesthesia with sevoflurane.
Propofol Target controlled infusion anesthesia with propofol for induction and maintenance.
Propofol Induction Sevoflurane Maintenance Propofol induction and sevoflurane maintenance anesthesia.

Participant Flow:   Overall Study
    Sevoflurane     Propofol     Propofol Induction Sevoflurane Maintenance  
STARTED     112     111 [1]   111 [1]
COMPLETED     109     107     111  
NOT COMPLETED     3     4     0  
[1] Data was not collected for 1 subject for baseline characteristics or the full analysis set.



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Sevoflurane Inhalational induction and maintenance anesthesia with sevoflurane.
Propofol Target controlled infusion anesthesia with propofol for induction and maintenance.
Propofol Induction Sevoflurane Maintenance Propofol induction and sevoflurane maintenance anesthesia.
Total Total of all reporting groups

Baseline Measures
    Sevoflurane     Propofol     Propofol Induction Sevoflurane Maintenance     Total  
Number of Participants  
[units: participants]
  112     111     111     334  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     112     111     111     334  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.29  ± 12.15     43.26  ± 12.05     42.51  ± 11.81     42.71  ± 11.96  
Gender  
[units: participants]
       
Female     92     92     87     271  
Male     20     19     24     63  
Region of Enrollment  
[units: participants]
       
China     112     111     111     334  



  Outcome Measures
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1.  Primary:   Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane   [ Time Frame: Anesthetic Duration between 1 to 3 Hours ]

2.  Secondary:   Time to Loss of Consciousness   [ Time Frame: Up to 10 minutes ]

3.  Secondary:   Time to Eye Opening   [ Time Frame: Every minute after anesthesia was stopped until the subjects' eyes opened ]

4.  Secondary:   Time to Extubation   [ Time Frame: Every minute after anesthesia was stopped until extubation occurred ]

5.  Secondary:   Time to Orientation   [ Time Frame: Every minute after anesthesia was stopped until orientation occurred ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Abbott
phone: 800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01191476     History of Changes
Other Study ID Numbers: R12-564
Study First Received: August 27, 2010
Results First Received: May 31, 2012
Last Updated: May 31, 2012
Health Authority: China: Food and Drug Administration