Preoperative-scheduled sedation in surgical patients admitted in the Intensive Care Unit (ICU) for postoperative monitoring MedDRA version: 21.1 Level: LLT Classification code 10049124 Term: Sedation during medical procedure System Organ Class: 100000004865
Conditions
Interventions
Trade Name: SEVOFLURANE PIRAMAL - 100% V/V LIQUIDO PER INALAZIONE 1 FLACONE IN VETRO DA 250 ML
Product Name: Sevoflurano
Product Code: N01AB08
Pharmaceutical Form: Pressurised inhalation, solution
IN
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Consent, obtained during the preoperative period, for data treatment , randomization and participation in the study. • Age > 18 years • Pre-operative indications for post-operative monitoring in the ICU Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Pregnancy and breast feeding (women of childbearing age will be tested for the beta-HCG dosage to certainy exclude the pregnancy before the enrollment). • Known hypersensitivity to propofol, soy, peanut or any of the excipients of the emulsion, as well as allergic patients to soy or peanut. • Patients undergoing treatment with Cyclosporine. • Severe or suspected hypersensitivity to sevoflurane or other halogenated anesthetics (eg history of liver dysfunction, fever or leukocytosis of unknown cause after anesthesia with one of these agents). • Moderate to severe hepatic dysfunction due to jaundice, fever, and eosinophilia after Sevoflurane-induced anesthesia. • Genetic predisposition known or suspected of malignant hyperthermia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate the reduction of the extubation time in the Sevoflurane sedated group compared to the group of patients sedated with Propofol, starting from similar depth of sedation.;Secondary Objective: Evaluate the total duration of mechanical ventilation in the ICU between the two study groups. Evaluate the hemodynamic pattern in patients sedated with Sevoflurane compared to patients sedated with Propofol. Evaluate the quality of waking in patients sedated with Sevoflurane compared with patients sedated with Propofol. Assess the quality of sleep during sedation with Sevoflurane compared to Propofol. Quantify plasma and urine inorganic fluoride concentration during sedation. Evaluate the outcome of patients in the two study groups. Evaluate the glicaemic stability in the two study groups.;Primary end point(s): The extubation time will be evaluated quantitatively: when the ICU physician will consider the patient ready to be weaned from mechanical ventilation (according to routine clinical criteria) sedation with Propofol or Sevoflurane will be suspended. From the "stop" of sedation the time needed to allow a complite consciousness and safetly extubation will be recorded. ;Timepoint(s) of evaluation of this end point: In the two study groups we will compare the time required from the patients to be safetly extubated from the Prpofol or Sevoflurane interruption. This data (expressed in minutes) will be reported as median and interquartile range and formaly recorded at the time of extubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): We will evaluate the total duration of mechanical ventilation (calcolated in minutes) between the two study groups, from the admission in the ICU to the removal of the orotracheal tube.; From the admission in the ICU systolic, diastolic and meanl arterial blood pressure will be recorded (in mmHg), as well as the heart rate (bpm) and the need for inotropic / vasopressor support (in mcg/kg/min).; The quality of patients awakening will be evaluated trought the "Richmond Agitation-Sedation Scale" after the extubation.; The quality of sleep will be evaluated in the two study groups through a sleep profiler: comparing the total sleep time (TST, in minutes) and the percentages of N1, N2 and N3 spleep compared to TST (in percentages) in the first 12 hours of sedation.; The plasmatic and urinary inorganic fluoride concentrations (in ppm) will be measured by PH-meter with ion-selective probe.; The outcome of the patients will be expressed in terms of: ICU lenght of stay (day), hospital lenght of stay (day), ICU mortality (percentage), and hospital mortality (percentage).; Glicaemic metabolic control will be expressed as glucose variability (ratio between standard deviation of glicaemia and the means observed during the sedation).;Timepoint(s) of evaluation of this end point: This timing will be expressed in minutes, it will be recorde at the time of extubation and will be compared in the final analysis between the two groups. ; All these parameters will be measured hourly during the entire sedation.; This evaluation will be performed 30 minutes after the extubation.; This evaluation will be continuously performed in the first 12 hours of sedation.; These concentrations will be evaluated at the time of extubation and after 24 hours. ; These assesments will be performed at the ICU discharge and at the hospital discharge or at the patient's death.; Glucose variability will be expressed at the end of the study considering all glicaemia values observed at h | — |
Countries
Italy
Contacts
Public ContactSOD Anestesia Oncologica e Terapia
Gianluca Villa
Outcome results
None listed