Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01749631
First received: December 12, 2012
Last updated: February 2, 2016
Last verified: February 2016
Results First Received: February 2, 2016  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Intubation; Difficult

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 97 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant did not meet the criteria Mallampati Score III or IV and was excluded from the per protocol population, which consisted of 96 participants.

Reporting Groups
  Description
Difficult to Intubate (DTI) Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

Participant Flow:   Overall Study
    Difficult to Intubate (DTI) Participants  
STARTED     97  
COMPLETED     97  
NOT COMPLETED     0  



  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.
Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.

Reporting Groups
  Description
Difficult to Intubate (DTI) Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

Baseline Measures
    Difficult to Intubate (DTI) Participants  
Number of Participants  
[units: participants]
  96  
Age  
[units: years]
Mean (Standard Deviation)
  48.8  (15.04)  
Gender  
[units: participants]
 
Female     54  
Male     42  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Successful Intubation (Clinical Success)   [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ]

2.  Secondary:   Mean Duration of Induction (in Seconds)   [ Time Frame: From start of induction up to 15 minutes ]

3.  Secondary:   Percentage of Participants With Mallampati Score III and IV   [ Time Frame: Screening ]

4.  Secondary:   Mean Duration of Intubation Procedure (in Minutes)   [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ]

5.  Secondary:   Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure   [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ]

6.  Secondary:   Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane   [ Time Frame: From start of induction to completion of intubation (up to 30 minutes) ]

7.  Secondary:   Mean Number of Intubation Attempts   [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ]


  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 Information
Organization: AbbVie
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01749631     History of Changes
Other Study ID Numbers: P13-805
Study First Received: December 12, 2012
Results First Received: February 2, 2016
Last Updated: February 2, 2016
Health Authority: Egypt: Ministry of Health and Population