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Patients Requiring Ambulatory Surgery Under General AnesthesiaPhase 4SC50NCT01974648

Propofol for Supreme LMA Insertion With and Without Remifentanil

A Phase 4 study testing propofol and propofol and remifentanil in people with Patients Requiring Ambulatory Surgery Under General Anesthesia, 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 aims of this study were to determine the clinically required concentration of propofol for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of propofol and improves conditions for it's insertion. Read more about this study

Who is it for?
Any age
What is being tested?
propofol and propofol and remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteSpain
Study dates
May 2012to Jun 2013
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patients with a potentially difficult airway o (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
  • Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación

    Madrid, Madrid, 28007

Other trials in Spain

About this study

Official title: ED 50 of Propofol for Supreme LMA Insertion With and Without Remifentanil. A Randomized Trial

The aims of this study were to determine the clinically required concentration of propofol for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of propofol and improves conditions for it's insertion.

Read the detailed description

The single-use Laryngeal Mask Airway SupremeTM (SLMA, Laryngeal Mask Company Limited, Singapore) is a new single use supraglottic airway device introduced recently that present combined features of the LMA ProSealTM (PLMA, Laryngeal Mask Company Limited) and the LMA FastrachTM (FLMA, Laryngeal Mask Company Limited). The mask has an anatomically shaped airway tube, elliptical in cross-section that facilitates easy insertion and minimizes accidental rotation. The cuff bowl is designed to prevent airway kinking and offer higher airway seal pressures around the laryngeal opening than the LMA ClassicTM (CLMA, Laryngeal Mask Company Limited) It has a drain tube that provides functional separation of the respiratory and digestive tracts to prevent gastric aspiration. Even though insertion of the SLMA is 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 SLMA originate from research involving other assessments of the SLMA such as the seal with respiratory and gastrointestinal tract.We tested for differences in the predicted concentration of propofol with and without remifentanil for insertion of the SLMA.

Methods: 50 patients ASA class I or II aged 18-75 years undergoing ambulatory elective surgery will be randomized to one of two groups: those who receive propofol + saline (control group: n = 25) or propofol + remifentanil (propofol-remifentanil group: n=25). We will use target-controled infusions (Alaris®PK) for both drugs: propofol (Marsh et al.´s pharmacokinetic model) and remifentanil (Minto et al.´s pharmacokinetic model). The patients wil be premedicated with midazolam 1 mg iv before surgery. The target concentration for each patient was determined using the Dixon´s up-and-down method. Predetermined propofol and remifentanil blood and effect site concentrations were held constant for at least 10 min. After equilibration of plasma and effect site propofol concentrations, the SLMA will be inserted, and secured according to the manufacture´s recommendations, without the use of muscle relaxants. In control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline. In propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered. A single measurement will be obtained from each patient. If the patient reacted with movement, the propofol concentration for the next patient was increased by 0.5 μg ml-1 ±1 ; if there was no movement, it was decreased by 0.5 μg ml-1 ±1 . Movement was defined as bucking or gross purposeful muscular movement within 1 min of LMA insertion. Values of Cp 50 wil be determined by calculating the midpoint concentration after at least seven crossover points (movement/non movement) will be obtained in each group.

Being tested
propofol, propofol and remifentanil
Keywords
Laryngeal Mask Airway Supreme, propofol, remifentanil, effective dose of intravenous propofol, ED50

What participants receive

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

  • propofolDrug

  • propofol and remifentanilDrug

Study groups in NCT01974648
Study groupRoleWhat they receive
propofolActive comparatorIn control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline.
Receives: Drug: propofol
propofol and remifentanilExperimentalIn propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered.
Receives: Drug: propofol and remifentanil

What is being measured

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

  1. The concentration of propofol with and without remifentanil for insertion of the SLMA

    Comparison of he concentration of propofol with and without remifentanil for insertion of the SLMA

    Measured: at insertion of SLMA

Secondary outcomes (5)
  1. changes in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate

    Measured: basal and every 3 minutes until 6 minutes after insertion of the SLMA

  2. BIS

    BIS data after SLMA insertion with both anaesthetic techniques

    Measured: before and after SLMA insertion(every min until min 6)

  3. Fibrescope evaluation

    Fibrescope evaluation of the SLMA Of the view of the glottis

    Measured: after SLMA insertion

  4. blood pressure(Hypertension or hypotension)

    Measured: before and after SLMA insertion(every min until min 6)

  5. heart rate (tachycardia or bradycardia)

    tachycardia or bradycardia requiring treatment

    Measured: before and after SLMA insertion(every min until min 6)

Timeline

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

  1. First posted1 Nov 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionJun 2013
  4. Study completionJun 2013

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974648
Sponsor's protocol ID
FIBHGMECNC002-2011
Acronym
SC50
Status last verified
Oct 2013
First submitted
21 Oct 2013
Last updated
1 Nov 2013
Results posted
No
Data monitoring committee
No

Publications

  • Zaballos M, Bastida E, Agusti S, Portas M, Jimenez C, Lopez-Gil M. Effect-site concentration of propofol required for LMA-Supreme insertion with and without remifentanil: a randomized controlled trial. BMC Anesthesiol. 2015 Oct 6;15:131. doi: 10.1186/s12871-015-0115-8.

    PubMed 26438179

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing propofol and propofol and remifentanil in people with Patients Requiring Ambulatory Surgery Under General Anesthesia, 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 1 inclusion and 1 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 1 Nov 2013. 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?

The concentration of propofol with and without remifentanil for insertion of the SLMA (time frame: at insertion of SLMA). 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 NCT01974648, 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 1 Nov 2013.

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