NCT01202162

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

July 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

September 13, 2010

Results QC Date

April 8, 2013

Last Update Submit

October 29, 2013

Conditions

Keywords

InductionCoughingAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Time to Awakening

    Time inhalational agent is turned off to time of patient awakening

Secondary Outcomes (2)

  • Number of Participants Who Coughed

    Perioperative

  • Quality of Recovery 40

    1 day

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

Administration of Desflurane

Drug: Desflurane

Sevoflurane

ACTIVE COMPARATOR

Administration of Sevoflurane

Drug: Administration of Sevoflurane

Interventions

Administratino of Desflurane

Desflurane

Administration of Sevoflurane

Sevoflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Female patients undergoing outpatient gynecologic and breast surgery
  • Under general anesthesia using an LMA
  • ASA I,II,

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

  • 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.

    PMID: 19820242BACKGROUND
  • 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.

    PMID: 17056947BACKGROUND
  • 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.

    PMID: 12598249BACKGROUND
  • 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.

    PMID: 16129973BACKGROUND
  • 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.

    PMID: 11167479BACKGROUND

MeSH Terms

Conditions

Cough

Interventions

Desflurane

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Limitations and 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.

Results Point of Contact

Title
Gildasio De Oliveira, M.D.
Organization
Northwestern University

Study Officials

  • Gildasio De Oliveira, M.D

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 15, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 25, 2013

Results First Posted

July 25, 2013

Record last verified: 2013-10

Locations