The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia

Sponsor
Chiang Mai University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03006250
Collaborator
(none)
220
2
2
35
110
3.1

Study Details

Study Description

Brief Summary

The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on respiratory events during a less than 2-hour elective surgery.

Detailed Description

Laryngeal Mask Airway (LMA) anesthesia is generally performed for ambulatory surgery to avoid the use of neuromuscular blocking agents and to facilitate rapid emergence from anesthesia. Inhaled anesthetics are simply and popularly used during maintenance of anesthesia. The two most recent volatile anesthetic agents, desflurane and sevoflurane, are the two most commonly used in clinical practice for an ambulatory setting.

Desflurane is the volatile agent with low blood: gas partition coefficient (0.42). Desflurane's uptake and elimination from the body of a patient are rapid, which results in a fast onset of anesthesia and a fast recovery from anesthesia. This property provides desflurane as an ideal agent for the ambulatory anesthesia. However, its pungent odor is concerned to irritate the upper airway and may cause significant respiratory complications. Sevoflurane has a blood: gas partition coefficient of 0.65, which is slightly greater than desflurane. The major advantage over desflurane is the better scent. It is considered to be less airway irritation in LMA anesthesia with smooth induction and recovery.

The limitation of desflurane on its odor leads to a controversy if desflurane is similar to or worse than sevoflurane for LMA anesthesia. This is non-inferiority study designed to compare the occurrence of respiratory complications between desflurane and sevoflurane during LMA anesthesia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia: A Prospective Randomized Double-blinded Control Study
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Desflurane

Desflurane group: The rule of 24 will be applied, which means that the fresh gas flow (l/ min) multiplied by volume percent of desflurane must not exceed 24. Therefore, once the patients return of spontaneous ventilation, an anesthesiologist turns on oxygen 1 l/ min, nitrous oxide 1 l/ min, and desflurane 12 vol% for 1-2 minutes. When the end-tidal desflurane reaches 3-3.5% (approximately 0.5 MAC), the anesthesiologist will decrease oxygen and nitrous oxide to each 0.5 l/ min and desflurane to 6 vol% (1 MAC). Desflurane concentration will be adjusted to maintain the end-tidal desflurane around 3-6% (0.5-1 MAC).

Drug: Desflurane
Desflurane is the volatile agent with low blood: gas partition coefficient (0.42), its uptake and elimination from the body of a patient are rapid, which results in a fast onset of anesthesia and a fast recovery from anesthesia. This property provides desflurane as an ideal agent for the ambulatory anesthesia. However, its pungent odor is concerned to irritate the upper airway and may cause significant respiratory complications.
Other Names:
  • Des
  • Active Comparator: Sevoflurane

    Sevoflurane group: The oxygen and nitrous oxide each 1 l/min will be turned on with sevoflurane 4 vol% for 1-2 minutes or until the end-tidal sevoflurane reach 1-1.2% (approximately 0.5 MAC). After that, the flow of oxygen and nitrous oxide is reduced to each 0.5 l/ min and concentration dial of sevoflurane is set to 2 vol% (1 MAC). During the operation, sevoflurane concentration will be adjusted to maintain the end-tidal sevoflurane around 1-2% (0.5-1 MAC)

    Drug: Sevoflurane
    Sevoflurane has a blood: gas partition coefficient of 0.65, which is slightly greater than desflurane. The major advantage over desflurane is the better scented. It is considered to be less airway irritation in LMA anesthesia with smooth induction and recovery.
    Other Names:
  • Sev
  • Outcome Measures

    Primary Outcome Measures

    1. Occurrence of respiratory complications [From the beginning of operation until 30 minutes after the operation]

      Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation

    Secondary Outcome Measures

    1. Time of eye opening [Within 30 minutes after the end of operation]

      It is the time from discontinuation of anesthetic to the eye opening on verbal command.

    2. Time to follow motor command [Within 30 minutes after the end of operation]

      It is the time from discontinuation of anesthetic to hand squeezing.

    3. Time of LMA removal [Within 30 minutes after the end of operation]

      It is the time from discontinuation of anesthetic to removal of LMA.

    4. Frequency of postoperative nausea and vomiting (PONV) [Within 2 hours after operation]

      It is a number of patients with PONV in the early post-anesthetic period.

    5. Changes of blood pressure during anesthesia [Every 15 minutes, from the beginning of operation until 30 minutes after the operation]

      Non-invasive blood pressure will be recorded at the beginning of anesthesia, every 15 minutes during anesthetic maintenance, and at the time of LMA removal.

    6. Changes of heart rate during anesthesia [Every 15 minutes, from the beginning of operation until 30 minutes after the operation]

      Heart rate will be recorded at the beginning of anesthesia, every 15 minutes during anesthetic maintenance, and at the time of LMA removal.

    Other Outcome Measures

    1. Time to achieve a satisfied Modified Aldrete score [Within 2 hours after operation]

      It is the time that the patient is ready to be discharged from post-anesthetic care unit.

    2. Number of Patients with high satisfaction to anesthesia [At 12-24 hour after surgery]

      The satisfaction is graded using a 5-point rating scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Patients with American Society of Anesthesiologists physical status classification of I-III

    • Elective surgery

    • Surgery with expected duration of operation of less than 2 hours

    • Surgery that anesthesiologist plans to use laryngeal mask airway during anesthesia

    Exclusion Criteria:
    • Patients with gastroesophageal reflux disease

    • Patients with hiatal hernia

    • Patients with history of upper respiratory tract infection within 1 month before surgery

    • Heavy smoker (> 20 cigarettes per day)

    • Obese patients with body mass index > 30kg/m2

    • Pregnant patients

    • Unable to provide a written informed consent patients

    • Surgery requiring non-depolarizing muscle relaxants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chiang Mai University Chiang Mai Thailand 50200
    2 Chiang Mai University Chiang Mai Thailand 50200

    Sponsors and Collaborators

    • Chiang Mai University

    Investigators

    • Principal Investigator: Pathomporn Pin-on, M.D., Maharaj Nakorn Chiang Mai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Pathomporn Pin on, M.D., Associate Professor, Chiang Mai University
    ClinicalTrials.gov Identifier:
    NCT03006250
    Other Study ID Numbers:
    • 15072016
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Dec 28, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Pathomporn Pin on, M.D., Associate Professor, Chiang Mai University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 28, 2018