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.
Status | Completed |
Enrollment | 45 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - ASA I-II patients - Scheduled to ambulatory surgery - Need for general anaesthesia - General anaesthesia usually performed with laryngeal mask - Negative pregnancy test in women - Signed inform consent Exclusion Criteria: - Patients with a potentially difficult airway (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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Servicio de Anestesia, Hospital General Universitario Gregorio Marañón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario Gregorio Marañon |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the the minimum alveolar anesthetic concentration (determined at 1 atmosphere, that prevents movement in 50% of patients to LMAS vs. LMAP insertion) of sevoflurane with simultaneous remifentanil infusion in adult patients. | To compare the concentration of sevoflurane with concomitant remifentanil infusion required for LMAS insertion vs. the concentration of sevoflurane with concomitant remifentanil infusion required for LMAP insertion. | The sevoflurane concentration is obtained during the insertion of the LMAS or LMAP in patients, after anesthesia induction | Yes |
Secondary | Blood pressure in mmHg | To compare the evolution of blood pressure during insertion of LMAS group versus LMAP group | Baseline and every 3 minutes until 6 minutes after insertion of the LMAs | Yes |
Secondary | Heart rate in bpm, | To compare the evolution of heart rate during insertion of LMAS group versus LMAP group | Before and after LMAs insertion (every minute until 6 minutes) | Yes |
Secondary | BIS data, number from 100 (awake) to 40-45 (anesthetic status) | To compare the evolution of BIS values during insertion of LMAS group versus LMAP group | Before and after LMAs insertion (every minute until 6 minutes) | Yes |
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