Sevoflurane Clinical Trial
Official title:
Comparison of the Sevoflurane EC50 Values for Laryngeal Mask Airway Supreme Versus Laryngeal Mask Airway ProSeal Insertion During Target-controlled Infusion of Remifentanil. A Randomized Trial
The study was designed to determine and compare the sevoflurane EC50 optimal concentration for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during target-controlled infusion of remifentanil.
Since the introduction of the laryngeal mask airway (LMA), a number of new supraglottic
airway devices as the LMA-Supreme (LMAS) and the LMA ProSeal (LMAP) have been developed for
the management of the airway during general anesthesia, and specifically in the context of
day surgery. ProSeal laryngeal mask airway is a reusable device designed to separate the
gastrointestinal and respiratory tracts, thereby improving the airway seal pressure and
allowing for controlled ventilation more efficiently tan classic LMA. The LMAS was developed
in 2007 as a single-use device provided with gastric canal, and combine the features of both
intubating LMA and the LMAP. Recently, there has been a growing interest in these devices
because of favourable studies obtained in several anaesthetic contexts that have proven
their effectiveness and safety. Even though insertion of both devices were 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 both devices originate from research involving other assessments of the LMAs
such as the seal respiratory and gastrointestinal tract. Investigators tested for
differences in the predicted concentration of sevoflurane with remifentanil for the
insertion of the LMAS vs. LMAP.
Methods: 45 patients American Society of Anesthesiologists (ASA) class I or II aged 20-60
years undergoing ambulatory elective surgery were randomized to either the LMAS or LMAP. The
patients were premedicated with midazolam 1 mg iv before surgery. All patients were
preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was
primed with sevoflurane 5% at a fresh gas flow of 6 L/min for 1 min. Anaesthesia was induced
with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.
Simultaneously remifentanil at an effect-site of 4 ng/ml was started. Target-controlled
infusions was used (Alaris PK) for remifentanil administration. After loss of consciousness,
the inspired concentration of sevoflurane was changed to obtain a predetermined end-tidal
concentration. A single experienced anaesthetist in the use of supraglottic devices inserted
the devices according to the manufacturer's recommendations. The LMAs size was chosen
according to the sex of the patients, size 4 for women and size 5 for men; however for
patients weighing ≤50 kg a size 3 was inserted. Neuromuscular blocking agents were not
given. Two nurses, who were blinded to the anaesthetic concentration, classified responses
by the patient to LMA insertion as either "movement" or "not movement". Assesment was made
for jaw relaxation and graded with Muzi score. A Muzi score >2 was defined as a failure of
insertion. The end-tidal (ET) sevoflurane concentration used for each patient was determined
using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal
concentrations was maintained at 0.9-1.0 for at least 10 minutes to establish equilibration
before device insertion was attempted. The first patient received a 2.5% sevoflurane
concentration and the step size of increase/decrease was 0.5%. If the supraglottic device
(LMAS or LMAP) insertion was successful, sevoflurane concentration for the next patient was
decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the
next patient. For their comfort, patients experiencing movement received a 1-2 mg/kg bolus
dose of propofol.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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