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

C

Chiang Mai University

Status and phase

Unknown
Phase 4

Conditions

Laryngeal Masks
Anesthesia; Adverse Effect
Respiratory System Abnormalities

Treatments

Drug: Sevoflurane
Drug: Desflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT03006250
15072016

Details and patient eligibility

About

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

Full 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.

Enrollment

220 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

220 participants in 2 patient groups

Desflurane
Experimental group
Description:
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).
Treatment:
Drug: Desflurane
Sevoflurane
Active Comparator group
Description:
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)
Treatment:
Drug: Sevoflurane

Trial contacts and locations

1

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Central trial contact

Pathomporn Pin-on, M.D.; Prangmalee Leurcharusmee, M.D.

Data sourced from clinicaltrials.gov

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