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

Primary Purpose

Anesthesia; Adverse Effect, Laryngeal Masks, Respiratory System Abnormalities

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Desflurane
Sevoflurane
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia; Adverse Effect focused on measuring Desflurane, Sevoflurane, Respiratory Complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chiang Mai UniversityRecruiting
  • Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desflurane

Sevoflurane

Arm 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).

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)

Outcomes

Primary Outcome Measures

Occurrence of respiratory complications
Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation

Secondary Outcome Measures

Time of eye opening
It is the time from discontinuation of anesthetic to the eye opening on verbal command.
Time to follow motor command
It is the time from discontinuation of anesthetic to hand squeezing.
Time of LMA removal
It is the time from discontinuation of anesthetic to removal of LMA.
Frequency of postoperative nausea and vomiting (PONV)
It is a number of patients with PONV in the early post-anesthetic period.
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.
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.

Full Information

First Posted
July 24, 2016
Last Updated
December 26, 2018
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT03006250
Brief Title
The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia
Official Title
The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia: A Prospective Randomized Double-blinded Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Adverse Effect, Laryngeal Masks, Respiratory System Abnormalities
Keywords
Desflurane, Sevoflurane, Respiratory Complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Desflurane
Arm Type
Experimental
Arm 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).
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Des
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sev
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of respiratory complications
Description
Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation
Time Frame
From the beginning of operation until 30 minutes after the operation
Secondary Outcome Measure Information:
Title
Time of eye opening
Description
It is the time from discontinuation of anesthetic to the eye opening on verbal command.
Time Frame
Within 30 minutes after the end of operation
Title
Time to follow motor command
Description
It is the time from discontinuation of anesthetic to hand squeezing.
Time Frame
Within 30 minutes after the end of operation
Title
Time of LMA removal
Description
It is the time from discontinuation of anesthetic to removal of LMA.
Time Frame
Within 30 minutes after the end of operation
Title
Frequency of postoperative nausea and vomiting (PONV)
Description
It is a number of patients with PONV in the early post-anesthetic period.
Time Frame
Within 2 hours after operation
Title
Changes of blood pressure during anesthesia
Description
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.
Time Frame
Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Title
Changes of heart rate during anesthesia
Description
Heart rate will be recorded at the beginning of anesthesia, every 15 minutes during anesthetic maintenance, and at the time of LMA removal.
Time Frame
Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Other Pre-specified Outcome Measures:
Title
Time to achieve a satisfied Modified Aldrete score
Description
It is the time that the patient is ready to be discharged from post-anesthetic care unit.
Time Frame
Within 2 hours after operation
Title
Number of Patients with high satisfaction to anesthesia
Description
The satisfaction is graded using a 5-point rating scale.
Time Frame
At 12-24 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pathomporn Pin-on, M.D.
Phone
66-86-897-0009
Email
pinon.pathomporn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prangmalee Leurcharusmee, M.D.
Phone
66-89-759-2647
Email
prangmalee.l@cmu.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pathomporn Pin-on, M.D.
Organizational Affiliation
Maharaj Nakorn Chiang Mai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yodying Punjasawadwong, M.D.
Phone
66-81-992-8082
Email
ypunjasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Pathomporn Pin-on, M.D.
First Name & Middle Initial & Last Name & Degree
Prangmalee Leurcharusmee, M.D.
Facility Name
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yodying Punjasawadwong, M.D.
Phone
66-81-992-8082
Email
ypunjasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Pathomporm Pin-on, M.D.
First Name & Middle Initial & Last Name & Degree
Prangmalee Leurcharusmee, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators don't have a plan to share data. The investigators plan to make an individual participant data available only in site.
Citations:
PubMed Identifier
23965188
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.
Results Reference
background
PubMed Identifier
24095885
Citation
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.
Results Reference
background
PubMed Identifier
16179038
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. doi: 10.1111/j.1365-2044.2005.04279.x.
Results Reference
background
PubMed Identifier
12598249
Citation
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.
Results Reference
background
PubMed Identifier
17056947
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. doi: 10.1213/01.ane.0000237293.39466.65.
Results Reference
background
PubMed Identifier
15728054
Citation
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.
Results Reference
background
PubMed Identifier
19608808
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.
Results Reference
background
PubMed Identifier
11167479
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. doi: 10.1046/j.1365-2044.2001.01528.x.
Results Reference
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The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia

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