Surgery Clinical Trial
Official title:
A Comparison of Desflurane vs. Sevoflurane on Time to Awakening and the Incidence and Severity of Cough After Ambulatory Surgery Using Laryngeal Mask Airway
| Verified date | October 2013 |
| Source | Northwestern University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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:
1. 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
2. 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.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwestern University | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Northwestern University |
United States,
Arain SR, Shankar H, Ebert TJ. Desflurane enhances reactivity during the use of the laryngeal mask airway. Anesthesiology. 2005 Sep;103(3):495-9. — View Citation
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. — View Citation
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):701-5, table of contents. — View Citation
Mahmoud NA, Rose DJ, Laurence AS. Desflurane or sevoflurane for gynaecological day-case anaesthesia with spontaneous respiration? Anaesthesia. 2001 Feb;56(2):171-4. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Awakening | Time inhalational agent is turned off to time of patient awakening | No | |
| Secondary | Number of Participants Who Coughed | Perioperative | No | |
| Secondary | Quality of Recovery 40 | 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 | No |
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