Clinical trial NCT03006250: The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia; Adverse Effect
Laryngeal Masks
Respiratory System Abnormalities
Keywords: Desflurane
Sevoflurane
Respiratory Complications
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of respiratory complications
timeFrame: From the beginning of operation until 30 minutes after the operation
Secondary outcomes:
measure: Time of eye opening
timeFrame: Within 30 minutes after the end of operation
measure: Time to follow motor command
timeFrame: Within 30 minutes after the end of operation
measure: Time of LMA removal
timeFrame: Within 30 minutes after the end of operation
measure: Frequency of postoperative nausea and vomiting (PONV)
timeFrame: Within 2 hours after operation
measure: Changes of blood pressure during anesthesia
timeFrame: Every 15 minutes, from the beginning of operation until 30 minutes after the operation
measure: Changes of heart rate during anesthesia
timeFrame: Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Other outcomes:
measure: Time to achieve a satisfied Modified Aldrete score
timeFrame: Within 2 hours after operation
measure: Number of Patients with high satisfaction to anesthesia
timeFrame: At 12-24 hour after surgery
Locations:
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
Study officials:
affiliation: Maharaj Nakorn Chiang Mai Hospital
name: Pathomporn Pin-on, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Oliveira GS Jr, Girao W, Fitzgerald PC, McCarthy RJ. The effect of sevoflurane versus desflurane on the incidence of upper respiratory morbidity in patients undergoing general anesthesia with a Laryngeal Mask Airway: a meta-analysis of randomized controlled trials. J Clin Anesth. 2013 Sep;25(6):452-8. doi: 10.1016/j.jclinane.2013.03.012. Epub 2013 Aug 17.
citation: De Oliveira GS Jr, Fitzgerald PC, Ahmad S, Marcus RJ, McCarthy RJ. Desflurane/fentanyl compared with sevoflurane/fentanyl on awakening and quality of recovery in outpatient surgery using a laryngeal mask airway: a randomized, double-blinded controlled trial. J Clin Anesth. 2013 Dec;25(8):651-8. doi: 10.1016/j.jclinane.2013.07.006. Epub 2013 Oct 4.
citation: Goodwin N, Strong PJ, Sudhir G, Wilkes AR, Hall JE. Effect of breathing low concentrations of volatile anaesthetic agents on incidence of adverse airway events. Anaesthesia. 2005 Oct;60(10):955-9. doi: 10.1111/j.1365-2044.2005.04279.x.
citation: 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.
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. doi: 10.1213/01.ane.0000237293.39466.65.
citation: Mckay RE, Large MJC, Balea MC, Mckay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700. doi: 10.1213/01.ANE.0000146514.65070.AE.
citation: White PF, Tang J, Wender RH, Yumul R, Stokes OJ, Sloninsky A, Naruse R, Kariger R, Norel E, Mandel S, Webb T, Zaentz A. Desflurane versus sevoflurane for maintenance of outpatient anesthesia: the effect on early versus late recovery and perioperative coughing. Anesth Analg. 2009 Aug;109(2):387-93. doi: 10.1213/ane.0b013e3181adc21a.
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. doi: 10.1046/j.1365-2044.2001.01528.x.