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Clinical Trials/NCT03006250
NCT03006250
Unknown
Phase 4

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

Chiang Mai University1 site in 1 country220 target enrollmentAugust 2016

Overview

Phase
Phase 4
Intervention
Desflurane
Conditions
Anesthesia; Adverse Effect
Sponsor
Chiang Mai University
Enrollment
220
Locations
1
Primary Endpoint
Occurrence of respiratory complications
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
July 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pathomporn Pin on, M.D.

Associate Professor

Chiang Mai University

Eligibility Criteria

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

Arms & Interventions

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).

Intervention: Desflurane

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)

Intervention: Sevoflurane

Outcomes

Primary Outcomes

Occurrence of respiratory complications

Time Frame: From the beginning of operation until 30 minutes after the operation

Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation

Secondary Outcomes

  • Time to follow motor command(Within 30 minutes after the end of operation)
  • Frequency of postoperative nausea and vomiting (PONV)(Within 2 hours after operation)
  • Time of eye opening(Within 30 minutes after the end of operation)
  • Time of LMA removal(Within 30 minutes after the end of operation)
  • Changes of blood pressure during anesthesia(Every 15 minutes, from the beginning of operation until 30 minutes after the operation)
  • Changes of heart rate during anesthesia(Every 15 minutes, from the beginning of operation until 30 minutes after the operation)

Study Sites (1)

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