Propofol for Supreme LMA Insertion With and Without Remifentanil

Patients Requiring Ambulatory Surgery Under General Anesthesia Clinical Trial

— SC50  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974648
• Other study ID #: FIBHGMECNC002-2011
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2013
• Last updated: October 25, 2013
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Patients Requiring Ambulatory Surgery Under General Anesthesia

Intervention

Drug:
• propofol

• propofol and remifentanil

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at insertion of SLMA	No
Secondary	changes in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate		basal and every 3 minutes until 6 minutes after insertion of the SLMA	No
Secondary	BIS	BIS data after SLMA insertion with both anaesthetic techniques	before and after SLMA insertion(every min until min 6)	No
Secondary	Fibrescope evaluation	Fibrescope evaluation of the SLMA Of the view of the glottis	after SLMA insertion	No
Secondary	blood pressure(Hypertension or hypotension)		before and after SLMA insertion(every min until min 6)	Yes
Secondary	heart rate (tachycardia or bradycardia)	tachycardia or bradycardia requiring treatment	before and after SLMA insertion(every min until min 6)	Yes