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AzTrials

SevofluranePhase 4NCT03003377

Sevoflurane-remifentanil EC50 (The 50% Effective Concentration) Values for LMA-Supreme Versus LMA ProSeal Insertion

A Phase 4 study testing laryngeal mask supreme and laryngeal mask proseal in people with Sevoflurane, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study was designed to determine and compare the sevoflurane EC50 optimal concentration for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during target-controlled infusion of remifentanil. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Sevoflurane
What is being tested?
laryngeal mask supreme and laryngeal mask proseal
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSpain
Study dates
Nov 2014to Oct 2015
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • ASA I-II patients
  • Scheduled to ambulatory surgery
  • Need for general anaesthesia
  • General anaesthesia usually performed with laryngeal mask
  • Negative pregnancy test in women
  • Signed inform consent

Who cannot join

  • Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
  • Patients with reactive airway disease
  • Signs of upper respiratory infection
  • Patients who had a risk of gastric aspiration

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Servicio de Anestesia, Hospital General Universitario Gregorio Marañón

    Madrid, Madrid, 28007

Other trials in Spain

About this study

Official title: Comparison of the Sevoflurane EC50 Values for Laryngeal Mask Airway Supreme Versus Laryngeal Mask Airway ProSeal Insertion During Target-controlled Infusion of Remifentanil. A Randomized Trial

The study was designed to determine and compare the sevoflurane EC50 optimal concentration for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during target-controlled infusion of remifentanil.

Read the detailed description

Since the introduction of the laryngeal mask airway (LMA), a number of new supraglottic airway devices as the LMA-Supreme (LMAS) and the LMA ProSeal (LMAP) have been developed for the management of the airway during general anesthesia, and specifically in the context of day surgery. ProSeal laryngeal mask airway is a reusable device designed to separate the gastrointestinal and respiratory tracts, thereby improving the airway seal pressure and allowing for controlled ventilation more efficiently tan classic LMA. The LMAS was developed in 2007 as a single-use device provided with gastric canal, and combine the features of both intubating LMA and the LMAP. Recently, there has been a growing interest in these devices because of favourable studies obtained in several anaesthetic contexts that have proven their effectiveness and safety. Even though insertion of both devices were associated with a higher initial success rate, fewer airway manipulations and a safe and effective airway during anaesthesia, the anaesthetic techniques for its insertion were not standardised. Most available data on the requirements of anaesthetic drugs and co-induction agents used for insertion of both devices originate from research involving other assessments of the LMAs such as the seal respiratory and gastrointestinal tract. Investigators tested for differences in the predicted concentration of sevoflurane with remifentanil for the insertion of the LMAS vs. LMAP.

Methods: 45 patients American Society of Anesthesiologists (ASA) class I or II aged 20-60 years undergoing ambulatory elective surgery were randomized to either the LMAS or LMAP. The patients were premedicated with midazolam 1 mg iv before surgery. All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was primed with sevoflurane 5% at a fresh gas flow of 6 L/min for 1 min. Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min. Simultaneously remifentanil at an effect-site of 4 ng/ml was started. Target-controlled infusions was used (Alaris PK) for remifentanil administration. After loss of consciousness, the inspired concentration of sevoflurane was changed to obtain a predetermined end-tidal concentration. A single experienced anaesthetist in the use of supraglottic devices inserted the devices according to the manufacturer's recommendations. The LMAs size was chosen according to the sex of the patients, size 4 for women and size 5 for men; however for patients weighing ≤50 kg a size 3 was inserted. Neuromuscular blocking agents were not given. Two nurses, who were blinded to the anaesthetic concentration, classified responses by the patient to LMA insertion as either "movement" or "not movement". Assesment was made for jaw relaxation and graded with Muzi score. A Muzi score >2 was defined as a failure of insertion. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.9-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 2.5% sevoflurane concentration and the step size of increase/decrease was 0.5%. If the supraglottic device (LMAS or LMAP) insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the next patient. For their comfort, patients experiencing movement received a 1-2 mg/kg bolus dose of propofol.

Conditions
Sevoflurane
Being tested
laryngeal mask supreme, laryngeal mask proseal
Keywords
Sevoflurane, Remifentanil, Laryngeal mask supreme, laryngeal mask proseal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laryngeal mask supremeDevice

    Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml). The LMAS was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAS was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.

  • laryngeal mask prosealDevice

    Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml).The LMAP was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAP was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.

Study groups in NCT03003377
Study groupRoleWhat they receive
Device: laryngeal mask supremeExperimentalDetermine the Sevoflurane concentration associate with remifentanil for the insertion of the laryngeal mask supreme
Receives: Device: laryngeal mask supreme
Device: laryngeal mask prosealActive comparatorDetermine the Sevoflurane concentration associate with remifentanil for insertion of the laryngeal mask ProSeal
Receives: Device: laryngeal mask proseal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the the minimum alveolar anesthetic concentration (determined at 1 atmosphere, that prevents movement in 50% of patients to LMAS vs. LMAP insertion) of sevoflurane with simultaneous remifentanil infusion in adult patients.

    To compare the concentration of sevoflurane with concomitant remifentanil infusion required for LMAS insertion vs. the concentration of sevoflurane with concomitant remifentanil infusion required for LMAP insertion.

    Measured: The sevoflurane concentration is obtained during the insertion of the LMAS or LMAP in patients, after anesthesia induction

Secondary outcomes (3)
  1. Blood pressure in mmHg

    To compare the evolution of blood pressure during insertion of LMAS group versus LMAP group

    Measured: Baseline and every 3 minutes until 6 minutes after insertion of the LMAs

  2. Heart rate in bpm,

    To compare the evolution of heart rate during insertion of LMAS group versus LMAP group

    Measured: Before and after LMAs insertion (every minute until 6 minutes)

  3. BIS data, number from 100 (awake) to 40-45 (anesthetic status)

    To compare the evolution of BIS values during insertion of LMAS group versus LMAP group

    Measured: Before and after LMAs insertion (every minute until 6 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003377
Sponsor's protocol ID
CETSEVOREM
Status last verified
Dec 2016
First submitted
15 Nov 2016
Last updated
29 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Monteserin-Matesanz C, Gonzalez T, Anadon-Baselga MJ, Zaballos M. Supreme laryngeal mask airway insertion requires a lower concentration of sevoflurane than ProSeal laryngeal mask airway insertion during target-controlled remifentanil infusion: a prospective randomised controlled study. BMC Anesthesiol. 2020 Jan 7;20(1):5. doi: 10.1186/s12871-019-0921-5.

    PubMed 31910822

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing laryngeal mask supreme and laryngeal mask proseal in people with Sevoflurane, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

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 6 inclusion and 4 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: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the the minimum alveolar anesthetic concentration (determined at 1 atmosphere, that prevents movement in 50% of patients to LMAS vs. LMAP insertion) of sevoflurane with simultaneous remifentanil infusion in adult patients. (time frame: The sevoflurane concentration is obtained during the insertion of the LMAS or LMAP in patients, after anesthesia induction). 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 NCT03003377, which also lists 1 linked publication.

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 29 Dec 2016.

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