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Completed

NCT Number: NCT01974648

Propofol for Supreme LMA Insertion With and Without Remifentanil

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Propofol

Drug

propofol and remifentanil

Drug

Primary outcomes

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

    Time frame: at insertion of SLMA

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

Secondary outcomes

  1. changes in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate

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

  2. BIS

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

    BIS data after SLMA insertion with both anaesthetic techniques

  3. Fibrescope evaluation

    Time frame: after SLMA insertion

    Fibrescope evaluation of the SLMA Of the view of the glottis

  4. blood pressure(Hypertension or hypotension)

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

  5. heart rate (tachycardia or bradycardia)

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

    tachycardia or bradycardia requiring treatment

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Collaborators

  • Ministry of Health, Spain

Registry information

Official study title

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

Acronym: SC50

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 1, 2013
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.