Anesthesia; Adverse EffectPhase 4NCT03006250
The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia
A Phase 4 study testing Desflurane and Sevoflurane in people with Anesthesia; Adverse Effect and Laryngeal Masks, run by Chiang Mai University at 2 sites in Thailand.
Trial summary
The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on respiratory events during a less than 2-hour elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia; Adverse Effect, Laryngeal Masks, Respiratory System Abnormalities
- What is being tested?
- Desflurane and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesThailand
- Study dates
- Aug 2016to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Chiang Mai University
Chiang Mai, 50200
Yodying Punjasawadwong, M.D., 66-81-992-8082, ypunjasa@gmail.com
Pathomporn Pin-on, M.D.
- Recruiting
Chiang Mai University
Chiang Mai, 50200
Yodying Punjasawadwong, M.D., 66-81-992-8082, ypunjasa@gmail.com
Pathomporm Pin-on, M.D.
About this study
Official title: The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia: A Prospective Randomized Double-blinded Control Study
The effects of desflurane versus sevoflurane in adult patients undergoing LMA anesthesia on respiratory events during a less than 2-hour elective surgery.
Read the 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.
- Being tested
- Desflurane, Sevoflurane
- Keywords
- Desflurane, Sevoflurane, Respiratory Complications
- Medical subject headings
- Respiratory System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called Des
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.
SevofluraneDrug
Also called Sev
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of respiratory complications
Respiratory complications are coughing, breath holding, laryngospasm, bronchospasm, and desaturation
Measured: From the beginning of operation until 30 minutes after the operation
Secondary outcomes (6)
Time of eye opening
It is the time from discontinuation of anesthetic to the eye opening on verbal command.
Measured: Within 30 minutes after the end of operation
Time to follow motor command
It is the time from discontinuation of anesthetic to hand squeezing.
Measured: Within 30 minutes after the end of operation
Time of LMA removal
It is the time from discontinuation of anesthetic to removal of LMA.
Measured: Within 30 minutes after the end of operation
Frequency of postoperative nausea and vomiting (PONV)
It is a number of patients with PONV in the early post-anesthetic period.
Measured: Within 2 hours after operation
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.
Measured: Every 15 minutes, from the beginning of operation until 30 minutes after the operation
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.
Measured: Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pathomporn Pin on, M.D., Chiang Mai University
- Investigators
- Pathomporn Pin-on, M.D., Principal investigator, Maharaj Nakorn Chiang Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006250
- Sponsor's protocol ID
- 15072016
- Status last verified
- Dec 2018
- First submitted
- 24 Jul 2016
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The investigators don't have a plan to share data. The investigators plan to make an individual participant data available only in site.
Publications
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.
PubMed 23965188De 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.
PubMed 24095885Goodwin 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.
PubMed 16179038White 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.
PubMed 12598249McKay 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.
PubMed 17056947Mckay 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.
PubMed 15728054White 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.
PubMed 19608808Mahmoud 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.
PubMed 11167479
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Desflurane vs Sevoflurane on Perioperative Respiratory Complications in Laryngeal Mask Airway Anesthesia: A Prospective Randomized Double-blinded Control Study
- ClinicalTrials.gov ID
- NCT03006250
- Acronym / sponsor ID
- 15072016
- Keywords
- Desflurane, Sevoflurane, Respiratory Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Drug: DesfluraneDesflurane 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 | Active comparator | Drug: SevofluraneSevoflurane 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesfluraneAlso: DesDesflurane 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. | Drug | Desflurane |
| SevofluraneAlso: SevSevoflurane 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. | Drug | Sevoflurane |
Primary outcome
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
6 secondary outcomes
Time of eye opening
Time frame: Within 30 minutes after the end of operation
Time to follow motor command
Time frame: Within 30 minutes after the end of operation
Time of LMA removal
Time frame: Within 30 minutes after the end of operation
Frequency of postoperative nausea and vomiting (PONV)
Time frame: Within 2 hours after operation
Changes of blood pressure during anesthesia
Time frame: Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Changes of heart rate during anesthesia
Time frame: Every 15 minutes, from the beginning of operation until 30 minutes after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Background: PubMed 23965188de 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.
- Background: PubMed 24095885De 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.
- Background: PubMed 16179038Goodwin 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.
- Background: PubMed 12598249White 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.
- Background: PubMed 17056947McKay 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.
- Background: PubMed 15728054Mckay 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.
- Background: PubMed 19608808White 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.
- Background: PubMed 11167479Mahmoud 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.
- Individual participant dataSharing planned: No. The investigators don't have a plan to share data. The investigators plan to make an individual participant data available only in site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pathomporn Pin-on, M.D. principal investigator
Maharaj Nakorn Chiang Mai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane and Sevoflurane in people with Anesthesia; Adverse Effect and Laryngeal Masks, run by Chiang Mai University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pathomporn Pin-on, M.D. (66-86-897-0009, pinon.pathomporn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of respiratory complications (time frame: From the beginning of operation until 30 minutes after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006250, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.