Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT03003377
Study type Interventional
Source Hospital General Universitario Gregorio Marañon
Contact
Status Completed
Phase Phase 4
Start date November 2014
Completion date October 2015

See also
  Status Clinical Trial Phase
Completed NCT06018597 - The Relationship of Sevoflurane Consumption With Metabolic Age
Completed NCT01219881 - Comparing Desflurane to Sevoflurane for the Effect on Recovery Time in Patients Undergoing Urological Cystoscope Surgery Phase 3
Completed NCT01096212 - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia Phase 4
Enrolling by invitation NCT05011214 - Comparison of Sedation by Esketamine and Sevoflurane Phase 4
Recruiting NCT06210061 - Propofol-Fentanyl-Dexmedetomidine and Propofol-Fentanyl-Sevoflurane Anesthesia for Major Spine Surgery Under Somato Sensory- and Motor- Evoked Potential Monitoring N/A
Completed NCT05554263 - Comparison of Automated Control Anesthesia and Manual Control Anesthesia in Minimal Flow Anesthesia
Completed NCT00949507 - Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia Phase 4
Not yet recruiting NCT06386965 - Sevoflurane Versus Propofol: Effect on Stress Response
Completed NCT01285271 - A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon Phase 3
Completed NCT04123249 - The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep N/A
Completed NCT06375863 - QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia N/A
Completed NCT01662622 - Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram Phase 4
Recruiting NCT06396468 - Sevoflurane and Intravenous Anesthesia in Hypospadias Repair N/A
Completed NCT04292561 - Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia N/A
Recruiting NCT04950205 - Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped Early Phase 1
Completed NCT01231477 - Cytokines and Sevoflurane During Surgery N/A
Completed NCT04431557 - The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.
Enrolling by invitation NCT03595163 - Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children N/A
Enrolling by invitation NCT03522402 - Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway N/A
Recruiting NCT03326960 - Sevoflurane, Propofol and Desflurane on POD/POCD