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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01202162
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Arms: 2
• Duration (Months): 24.9
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Anesthesia	Drug: Desflurane; Drug: Administration of Sevoflurane	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• 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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Desflurane Administration of Desflurane	Drug: Desflurane; Administratino of Desflurane
Active Comparator: Sevoflurane Administration of Sevoflurane	Drug: Administration of Sevoflurane; Administration of Sevoflurane

Outcome Measures

Primary Outcome Measures

1. Time to Awakening [Time inhalational agent is turned off to time of patient awakening]

Secondary Outcome Measures

1. Number of Participants Who Coughed [Perioperative]

2. Quality of Recovery 40 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Gildasio De Oliveira, M.D, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Arain SR, Shankar H, Ebert TJ. Desflurane enhances reactivity during the use of the laryngeal mask airway. Anesthesiology. 2005 Sep;103(3):495-9.
• 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.
• Mahmoud NA, Rose DJ, Laurence AS. Desflurane or sevoflurane for gynaecological day-case anaesthesia with spontaneous respiration? Anaesthesia. 2001 Feb;56(2):171-4.
• 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.
• 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.

• Responsible Party: Gildasio De Oliveira, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01202162
• Other Study ID Numbers: STU00036200
• First Posted: Sep 15, 2010
• Last Update Posted: Nov 25, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Gildasio De Oliveira, Principal Investigator, Northwestern University: Induction; Coughing; Anesthesia
• Additional relevant MeSH terms: Sevoflurane; Desflurane

Study Results

Participant Flow

Recruitment Details	85 Subjects were recruited and randomized and 80 completed the study. Subjects were consecutively enrolled from December 2010 through February 2012.

Arm/Group Title	Desflurane	Sevoflurane
Arm/Group Description	Administration of Desflurane	Administration of Sevoflurane
Period Title: Overall Study
STARTED	43	42
COMPLETED	40	40
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Desflurane	Sevoflurane	Total
Arm/Group Description	Administration of Desflurane	Administration of Sevoflurane	Total of all reporting groups
Overall Participants	43	42	85
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	43 100%	42 100%	85 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.2 (8.3)	39.9 (7.7)	40.6 (8.1)
Sex: Female, Male (Count of Participants)
Female	43 100%	42 100%	85 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	43 100%	42 100%	85 100%

Outcome Measures

1. Primary Outcome

Title	Time to Awakening
Time Frame	Time inhalational agent is turned off to time of patient awakening

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Desflurane	Sevoflurane
Arm/Group Description	Administration of Desflurane	Administration of Sevoflurane
Measure Participants	40	40
Median (Inter-Quartile Range) [Elapsed time in minutes]	6.8	11.8

2. Secondary Outcome

Title	Number of Participants Who Coughed
Time Frame	Perioperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Desflurane	Sevoflurane
Arm/Group Description	Administration of Desflurane	Administration of Sevoflurane
Measure Participants	40	40
Number [participants]	4 9.3%	7 16.7%

3. Secondary Outcome

Title	Quality of Recovery 40
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

Outcome Measure Data

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
Arm/Group Description	Administration of Desflurane	Administration of Sevoflurane
Measure Participants	35	33
Median (Inter-Quartile Range) [score (between 40 low-200 high)]	188	182

Adverse Events

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
Arm/Group Description	Administration of Desflurane		Administration of Sevoflurane
All Cause Mortality
	Desflurane		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Desflurane		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Desflurane		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/40 (5%)		1/40 (2.5%)
Respiratory, thoracic and mediastinal disorders
Laryngospasm	2/38 (5.3%)	2	1/39 (2.6%)	1

Limitations/Caveats

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.

More Information

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.