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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
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Hospital General Universitario Gregorio Marañon

Brief 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.

Condition or disease Intervention/treatment Phase
Patients Requiring Ambulatory Surgery Under General Anesthesia Drug: propofol Drug: propofol and remifentanil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: propofol
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974648


Locations
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Spain
Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Ministry of Health, Spain
Investigators
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Principal Investigator: Matilde Zaballos, PhD Hospital General Universitario Gregorio Marañón
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT01974648    
Other Study ID Numbers: FIBHGMECNC002-2011
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Keywords provided by Hospital General Universitario Gregorio Marañon:
Laryngeal Mask Airway Supreme
propofol
remifentanil
effective dose of intravenous propofol
ED50
Additional relevant MeSH terms:
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Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents