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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01202162
First received: September 13, 2010
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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 Intervention
Surgery
Anesthesia
Drug: Desflurane
Drug: Administration of Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Time to Awakening [ Time Frame: Time inhalational agent is turned off to time of patient awakening ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Who Coughed [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
  • Quality of Recovery 40 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Enrollment: 85
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Desflurane
Administration of Desflurane
Drug: Desflurane
Administratino of Desflurane
Active Comparator: Sevoflurane
Administration of Sevoflurane
Drug: Administration of Sevoflurane
Administration of Sevoflurane

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202162

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio De Oliveira, M.D Northwestern University
  More Information

Publications:
Responsible Party: Gildasio De Oliveira, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01202162     History of Changes
Other Study ID Numbers: STU00036200
Study First Received: September 13, 2010
Results First Received: April 8, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Induction
Coughing
Anesthesia

Additional relevant MeSH terms:
Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014