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

NCT03006250 | Unknown Phase 4 DMC

• 1 other identifier: 15072016
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthesia; Adverse Effect; Laryngeal Masks; Respiratory System Abnormalities

Keywords

Desflurane; Sevoflurane; Respiratory Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time of eye opening

  Within 30 minutes after the end of operation

• Time to follow motor command

  Within 30 minutes after the end of operation

• Time of LMA removal

  Within 30 minutes after the end of operation

• Frequency of postoperative nausea and vomiting (PONV)

  Within 2 hours after operation

• Changes of blood pressure during anesthesia

  Every 15 minutes, from the beginning of operation until 30 minutes after the operation

Other Outcomes (2)

• Time to achieve a satisfied Modified Aldrete score

  Within 2 hours after operation

• Number of Patients with high satisfaction to anesthesia

  At 12-24 hour after surgery

Study Arms (2)

Desflurane

EXPERIMENTAL

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

Sevoflurane

ACTIVE COMPARATOR

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

Interventions

Desflurane DRUG

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.

Also known as: Des

Desflurane

Sevoflurane DRUG

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.

Also known as: Sev

Sevoflurane

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (2)

Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (8)

• 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.

  PMID: 23965188 BACKGROUND

• 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.

  PMID: 24095885 BACKGROUND

• 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.

  PMID: 16179038 BACKGROUND

• 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.

  PMID: 12598249 BACKGROUND

• 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.

  PMID: 17056947 BACKGROUND

• 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.

  PMID: 15728054 BACKGROUND

• 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.

  PMID: 19608808 BACKGROUND

• 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.

  PMID: 11167479 BACKGROUND

MeSH Terms

Conditions

Respiratory System Abnormalities

Interventions

Desflurane; Desmin; Sevoflurane

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Intermediate Filament Proteins; Biopolymers; Polymers; Macromolecular Substances; Cytoskeletal Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Pathomporn Pin-on, M.D.

  Maharaj Nakorn Chiang Mai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pathomporn Pin-on, M.D.

CONTACT

66-86-897-0009; pinon.pathomporn@gmail.com

Prangmalee Leurcharusmee, M.D.

CONTACT

66-89-759-2647; prangmalee.l@cmu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2016
• First Posted: December 30, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)