Propofol for Supreme LMA Insertion With and Without Remifentanil (SC50)
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|ClinicalTrials.gov Identifier: NCT01974648|
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : November 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Patients Requiring Ambulatory Surgery Under General Anesthesia||Drug: propofol Drug: propofol and remifentanil||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||ED 50 of Propofol for Supreme LMA Insertion With and Without Remifentanil. A Randomized Trial|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: propofol
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.
Experimental: propofol and remifentanil
In propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered.
Drug: propofol and remifentanil
- 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
- 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 ]
- BIS [ Time Frame: before and after SLMA insertion(every min until min 6) ]BIS data after SLMA insertion with both anaesthetic techniques
- Fibrescope evaluation [ Time Frame: after SLMA insertion ]Fibrescope evaluation of the SLMA Of the view of the glottis
- blood pressure(Hypertension or hypotension) [ Time Frame: before and after SLMA insertion(every min until min 6) ]
- heart rate (tachycardia or bradycardia) [ Time Frame: before and after SLMA insertion(every min until min 6) ]tachycardia or bradycardia requiring treatment
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974648
|Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación|
|Madrid, Spain, 28007|
|Principal Investigator:||Matilde Zaballos, PhD||Hospital General Universitario Gregorio Marañón|