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

Anesthesia; Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006250
• Other study ID #: 15072016
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: July 2019

Study information

• Verified date: December 2018
• Source: Chiang Mai University
• Contact: Pathomporn Pin-on, M.D.
• Phone: 66-86-897-0009
• Email: pinon.pathomporn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Laryngeal Masks
• Respiratory System Abnormalities

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Chiang Mai University	Chiang Mai
Thailand	Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

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. — View 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. — View Citation

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):701-5, table of contents. — View 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. — View 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. — View 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. — View Citation

McKay RE, Large MJ, Balea MC, McKay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700, table of contents. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of Patients with high satisfaction to anesthesia	The satisfaction is graded using a 5-point rating scale.	At 12-24 hour after surgery
Primary	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	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
Secondary	Time to follow motor command	It is the time from discontinuation of anesthetic to hand squeezing.	Within 30 minutes after the end of operation
Secondary	Time of LMA removal	It is the time from discontinuation of anesthetic to removal of LMA.	Within 30 minutes after the end of operation
Secondary	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
Secondary	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
Secondary	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