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

The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia: A Prospective Randomized Double-blinded Control Study

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

Study Overview

• Status: Unknown
• Conditions: Laryngeal Masks; Respiratory System Abnormalities; Anesthesia; Adverse Effect
• Intervention / Treatment: Drug: Desflurane; Drug: Sevoflurane

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pathomporn Pin-on, M.D.; Phone Number: 66-86-897-0009; Email: pinon.pathomporn@gmail.com
• Study Contact Backup: Name: Prangmalee Leurcharusmee, M.D.; Phone Number: 66-89-759-2647; Email: prangmalee.l@cmu.ac.th

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Chiang Mai University
    • Contact: Yodying Punjasawadwong, M.D.; Phone Number: 66-81-992-8082; Email: ypunjasa@gmail.com
    • Sub-Investigator: Prangmalee Leurcharusmee, M.D.
    • Principal Investigator: Pathomporm Pin-on, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of respiratory complications	Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation	From the beginning of operation until 30 minutes after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of eye opening	It is the time from discontinuation of anesthetic to the eye opening on verbal command.	Within 30 minutes after the end of operation
Time to follow motor command	It is the time from discontinuation of anesthetic to hand squeezing.	Within 30 minutes after the end of operation
Time of LMA removal	It is the time from discontinuation of anesthetic to removal of LMA.	Within 30 minutes after the end of operation
Frequency of postoperative nausea and vomiting (PONV)	It is a number of patients with PONV in the early post-anesthetic period.	Within 2 hours after operation
Changes of blood pressure during anesthesia	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.	Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Changes of heart rate during anesthesia	Heart rate will be recorded at the beginning of anesthesia, every 15 minutes during anesthetic maintenance, and at the time of LMA removal.	Every 15 minutes, from the beginning of operation until 30 minutes after the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve a satisfied Modified Aldrete score	It is the time that the patient is ready to be discharged from post-anesthetic care unit.	Within 2 hours after operation
Number of Patients with high satisfaction to anesthesia	The satisfaction is graded using a 5-point rating scale.	At 12-24 hour after surgery

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: July 24, 2016
• First Submitted That Met QC Criteria: December 26, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Desflurane; Sevoflurane; Respiratory Complications
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Congenital Abnormalities; Respiratory System Abnormalities; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Desflurane; Sevoflurane
• Other Study ID Numbers: 15072016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators don't have a plan to share data. The investigators plan to make an individual participant data available only in site.