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

Phase 4

• Conditions: Anesthesia; Adverse Effect; Laryngeal Masks; Respiratory System Abnormalities
• Interventions: Drug: Desflurane; Drug: Sevoflurane

• Registration Number: NCT03006250
• Lead Sponsor: Chiang Mai University

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.

Study Timeline

• Study First Submitted: 2016-07-24
• Study Start: 2016-08
• Study First Submitted QC: 2016-12-26
• Study First Posted: 2016-12-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-26
• Last Update Posted: 2018-12-28
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane	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).
Sevoflurane	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)

Primary Outcome Measures

Name	Time	Method
Occurrence of respiratory complications	From the beginning of operation until 30 minutes after the operation	Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand