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Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment

This study has been completed.
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Girish P Joshi, MD, University of Texas Southwestern Medical Center Identifier:
First received: November 3, 2010
Last updated: March 14, 2013
Last verified: March 2013
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Administration Site Reaction
Intervention: Drug: Fentanyl

  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
Patients were recruited for the study in the preoperative period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were included based on inclusion/exclusion criteria. Participants were excluded if muscle relaxation was necessary for the surgery.

Reporting Groups

Participant Flow:   Overall Study
STARTED   51   49 
COMPLETED   49   47 
Physician Decision                2                2 

  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
Total Total of all reporting groups

Baseline Measures
Overall Participants 
[units: participants]
 49   47   96 
[units: participants]
<=18 years   0   0   0 
Between 18 and 65 years   49   47   96 
>=65 years   0   0   0 
[units: participants]
Female   25   25   50 
Male   24   22   46 
Body Mass Index [1] 
[units: kg/m2]
Mean (Standard Deviation)
 26.8  (4.3)   26.8  (4.7)   26.8  (4.5) 
[1] Body mass index is calculated from height and weight of the patient.

  Outcome Measures
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1.  Primary:   Movement   [ Time Frame: Induction of Anesthesia ]

2.  Secondary:   Apnea   [ Time Frame: Induction of Anesthesia ]

3.  Secondary:   Coughing   [ Time Frame: Intraoperative period ]

  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 NOT 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.

Results Point of Contact:  
Name/Title: Girish P. Joshi, MD
Organization: University of Texas Southwestern Medical Center at Dallas
phone: 214-590-7259

Responsible Party: Girish P Joshi, MD, University of Texas Southwestern Medical Center Identifier: NCT01277861     History of Changes
Other Study ID Numbers: 092010-013
Study First Received: November 3, 2010
Results First Received: February 16, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board