- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01202162
A Comparison of Desflurane vs. Sevoflurane and the Time to Awakening and the Incidence and Severity of Cough
A Comparison of Desflurane vs. Sevoflurane on Time to Awakening and the Incidence and Severity of Cough After Ambulatory Surgery Using Laryngeal Mask Airway
Goals for ambulatory surgery include providing optimal surgical conditions while ensuring a rapid early recovery without side effect. Dexter et al1 concluded in a meta-analysis that Desflurane can reduce the extubation time when compared to Sevoflurane. This potential benefit of Desflurane can be especially attractive in short ambulatory cases performed with general anesthesia with a laryngeal mask airway.
Although some studies have not shown a difference on perioperative cough and laryngospasm between Desflurane and Sevoflurane at clinically relevant doses.It has been reported in the literature that Desflurane causes cough4 and many providers avoid using Desflurane with a LMA (laryngeal mask airway) in the ambulatory setting. In this study we will also evaluate, as a secondary outcome, the presence and severity of perioperative cough and laryngospasm.
Previous investigators have demonstrated a more rapid resumption of normal daily activities after ambulatory surgery in patients anesthetized with Desflurane when compared with Sevoflurane.these investigators suggested a better quality of recovery when Desflurane is used probably due to a lower lipid solubility of Desflurane. We will also evaluate quality of recovery as a secondary outcome using a validated instrument.
Significance:
- A more rapid awakening, especially, in a fast and high turnover cases that are performed with LMA can lead to a more cost effective utilization of operating room time
- It has been reported that Desflurane causes more cough than Sevoflurane and Anesthesiologists avoid using Desflurane with LMA cases, this study will reinforce that there is no difference.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-65
- Female patients undergoing outpatient gynecologic and breast surgery
- Under general anesthesia using an LMA
- ASA I,II,
Exclusion Criteria:
- Patients on CNS depressants
- Chronic opioid use
- Corticosteroid
- Pregnant patients
- Full stomach
- Morbidly obese (BMI >35kg/m2)
- Hepatitis B
- Hepatitis C
- Coronary artery disease
- Liver disease
- Renal disease
- Seizure disorder
Dropout criteria:
- Need for endotracheal tube
- Surgeon or patient request
- Hospital admission
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Desflurane
Administration of Desflurane
|
Administratino of Desflurane
|
Active Comparator: Sevoflurane
Administration of Sevoflurane
|
Administration of Sevoflurane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Awakening
Time Frame: Time inhalational agent is turned off to time of patient awakening
|
Time inhalational agent is turned off to time of patient awakening
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Coughed
Time Frame: Perioperative
|
Perioperative
|
|
Quality of Recovery 40
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- White PF, Eshima RW, Maurer A, King T, Lin BK, Heavner JE, Bogetz MS, Kaye AD. A comparison of airway responses during desflurane and sevoflurane administration via a laryngeal mask airway for maintenance of anesthesia. Anesth Analg. 2003 Mar;96(3):701-705. doi: 10.1213/01.ANE.0000048978.40522.AB.
- McKay RE, Bostrom A, Balea MC, McKay WR. Airway responses during desflurane versus sevoflurane administration via a laryngeal mask airway in smokers. Anesth Analg. 2006 Nov;103(5):1147-54. doi: 10.1213/01.ane.0000237293.39466.65.
- Mahmoud NA, Rose DJ, Laurence AS. Desflurane or sevoflurane for gynaecological day-case anaesthesia with spontaneous respiration? Anaesthesia. 2001 Feb;56(2):171-4. doi: 10.1046/j.1365-2044.2001.01528.x.
- Dexter F, Bayman EO, Epstein RH. Statistical modeling of average and variability of time to extubation for meta-analysis comparing desflurane to sevoflurane. Anesth Analg. 2010 Feb 1;110(2):570-80. doi: 10.1213/ANE.0b013e3181b5dcb7. Epub 2009 Oct 9.
- Arain SR, Shankar H, Ebert TJ. Desflurane enhances reactivity during the use of the laryngeal mask airway. Anesthesiology. 2005 Sep;103(3):495-9. doi: 10.1097/00000542-200509000-00011.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00036200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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