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A Comparison of Desflurane vs. Sevoflurane and the Time to Awakening and the Incidence and Severity of Cough

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ClinicalTrials.gov Identifier: NCT01202162
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : July 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor)
Conditions Surgery
Anesthesia
Interventions Drug: Desflurane
Drug: Administration of Sevoflurane
Enrollment 85
Recruitment Details 85 Subjects were recruited and randomized and 80 completed the study. Subjects were consecutively enrolled from December 2010 through February 2012.
Pre-assignment Details  
Arm/Group Title Desflurane Sevoflurane
Hide Arm/Group Description Administration of Desflurane Administration of Sevoflurane
Period Title: Overall Study
Started 43 42
Completed 40 [1] 40 [1]
Not Completed 3 2
[1]
40 completed the intraoperative through discharge phase of the study.
Arm/Group Title Desflurane Sevoflurane Total
Hide Arm/Group Description Administration of Desflurane Administration of Sevoflurane Total of all reporting groups
Overall Number of Baseline Participants 43 42 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
42
 100.0%
85
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 85 participants
41.2  (8.3) 39.9  (7.7) 40.6  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 85 participants
Female
43
 100.0%
42
 100.0%
85
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 42 participants 85 participants
43 42 85
1.Primary Outcome
Title Time to Awakening
Hide Description [Not Specified]
Time Frame Time inhalational agent is turned off to time of patient awakening
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desflurane Sevoflurane
Hide Arm/Group Description:
Administration of Desflurane
Administration of Sevoflurane
Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: Elapsed time in minutes
6.8
(5.0 to 9.6)
11.8
(8.8 to 14.6)
2.Secondary Outcome
Title Number of Participants Who Coughed
Hide Description [Not Specified]
Time Frame Perioperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desflurane Sevoflurane
Hide Arm/Group Description:
Administration of Desflurane
Administration of Sevoflurane
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
4 7
3.Secondary Outcome
Title Quality of Recovery 40
Hide Description Survey completion at 24 hours post surgery of the Quality of Recovery 40 questionnaire.This questionnaire asks 40 questions in 5 categories of recovery. The scores are combined from each group and are used as a composite score. The scores range from a low of 40 to a high of 200. A score of 40 would indicate a poor quality of recovery where as a score of 200 would be a good quality of recovery at 24 hours postoperative.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
In the Desflurane group 35 completed the survey 24 hours postoperative where as 33 in the Sevoflurane completed the survey during the postoperative period.
Arm/Group Title Desflurane Sevoflurane
Hide Arm/Group Description:
Administration of Desflurane
Administration of Sevoflurane
Overall Number of Participants Analyzed 35 33
Median (Inter-Quartile Range)
Unit of Measure: score (between 40 low-200 high)
188
(185 to 191)
182
(176 to 190)
Time Frame Intraoperative period from induction of anesthesia until time of discharge from the operating room.
Adverse Event Reporting Description Laryngospasm occuring from the introduction of inhalation agent to time of discharge from the operating room
 
Arm/Group Title Desflurane Sevoflurane
Hide Arm/Group Description Administration of Desflurane Administration of Sevoflurane
All-Cause Mortality
Desflurane Sevoflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Desflurane Sevoflurane
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desflurane Sevoflurane
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/40 (5.00%)      1/40 (2.50%)    
Respiratory, thoracic and mediastinal disorders     
Laryngospasm  1  2/38 (5.26%)  2 1/39 (2.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Laryngospasm
Our study is only valid if interpreted within the context of its limitations. We have only evaluated female subjects undergoing ambulatory hysteroscopic surgery which limits the generalizability of our results.
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: Gildasio De Oliveira, M.D.
Organization: Northwestern University
Phone: 312-926-8371
Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01202162     History of Changes
Other Study ID Numbers: STU00036200
First Submitted: September 13, 2010
First Posted: September 15, 2010
Results First Submitted: April 8, 2013
Results First Posted: July 25, 2013
Last Update Posted: November 25, 2013