The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintenance period of general anaesthesia.
The inert or "noble" gas Xenon has anaesthetic properties that have been recognized 50 years ago. Several preclinical studies and investigations using xenon as an inhalational anaesthetic in humans were performed and reported that this gas has many properties of the ideal anaesthetic agent. Moreover, it is known that when xenon is combined with volatile anaesthetics or opioids, the required doses of those substances are reduced, resulting in a lower incidence of side effects. Patients could benefit from the administration of xenon if this inspired concentration would result in reduced doses of co-administered drugs. This trial should allow evaluating the propofol consumption required in combination with xenon administered in inspiratory concentrations of 50% and 70% to maintain comparable depth of general anaesthesia as total i.v. anaesthesia, in ASA III patients presenting increased risk of perioperative cardiac complications and undergoing laparotomy or orthopaedic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
102
Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.
Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.
Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
Groupe Hospitalier Universitaire Caremeau
Nîmes, France
Evangelisches Waldkrankenhaus Berlin-Spandau
Berlin, Germany
BG Kliniken-Bergmannstrost
Halle, Germany
Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)
Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.
Time frame: Maintenance period (1 Day)
Anaesthesia Recovery Time
Time interval between the end of maintenance period and time of tracheal tube removal.
Time frame: 1 Postoperative Day
Awakening Time
Time interval between the end of maintenance period and time of Aldrete score ≥ 9.
Time frame: 1 Postoperative Day
Stay in the Operating Room
Time interval between admission in the operating room and discharge from the operating room.
Time frame: 1 Postoperative Day
Stay in the Recovery Room
Time interval between admission in the recovery room and discharge from the recovery room.
Time frame: 1 Postoperative Day
Haematology - Leucocytes (Giga/L)
Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.
Time frame: 1 Postoperative Day
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University Hospital Schleswig-Holstein
Kiel, Germany
Manchester Royal Infirmary
Manchester, United Kingdom
Haematology - Erythrocytes (Tera/L)
Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.
Time frame: 1 Postoperative Day.
Haematology - Platelets (Giga/L)
Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery
Time frame: 1 Postoperative Day
Serum Chemistry - AST (GOT) (IU/L)
AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.
Time frame: 1 Postoperative Day
Serum Chemistry - ALT (GPT) (IU/L)
ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Time frame: 1 Postoperative Day
Serum Chemistry - Gamma GT (IU/L)
Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Time frame: 1 Postoperative Day
Serum Chemistry - Creatinine (Mcmol/L)
Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Time frame: 1 Postoperative Day
Serum Chemistry - Urea (mmol/L)
Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Time frame: 1 Postoperative Day