PROPOFOL

Propofol must only be administered in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. g. ECG, pulse oxymetry) and facilities for maintenance of a patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times.

For sedation during surgical and diagnostic procedures Propofol should not be administered by the same person conducting the surgical or diagnostic procedure. Propofol has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol.

Posology The dose of Propofol should be individually adapted according to the patient’s response. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. Propofol should not be used for bolus injection as this may lead to cardiorespiratory depression.

General anaesthesia in adults Induction of anaesthesia For induction of anaesthesia Propofol must be titrated (20-40 mg propofol every 10 seconds) against the response of the patient until clinical signs show the onset of anaesthesia.

5 mg/kg body weight. In patients over 55 years and in patients of ASA (American Society of Anaesthesiologists) classification III and IV, especially in those with impaired cardiac function the requirements will generally be less and the total dose of Propofol may be reduced to a minimum of 1 mg propofol/kg bodyweight.

These patients also need lower rates of administration (approximately 2 ml corresponding to 20 mg propofol every 10 seconds). Maintenance of anaesthesia Anaesthesia can be maintained by administering Propofol either by continuous infusion or repeat bolus injections (Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion only).

Continuous Infusion:

When using a continuous infusion for maintenance of anaesthesia generally doses of 4 to 12 mg/kg/h should be given. In older people, patients in unstable general conditions, patients with impaired cardiac function or hypovolaemic patients and patients of ASA grades III and IV, the dosage of Propofol may be further reduced depending on the patient’s condition and on the applied anaesthetic method.

5 up to 5 ml Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion) should be administered depending on the clinical requirements. Sedation of mechanically ventilated patients during intensive care Adults and adolescents (≥ 16 years of age) When used to provide sedation for mechanically ventilated patients under intensive care conditions, the administration of Propofol as continuous infusion it is recommended.

The rate of administration has to be adapted to the level of sedation required. 4). Administering Propofol through a TCI-system for sedation in intensive care is not recommended. It is recommended that blood lipid levels be monitored should Propofol be administered to patients thought to be at particular risk of fat overload.

Administration of Propofol should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. 1g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients.

Sedation for diagnostic and surgical procedures in adult patients To provide sedation during surgical and diagnostic procedures, doses and administration rates need to be adapted to the clinical response. 0 mg/kg body weight over 1 to 5 minutes for induction of sedation.

For maintenance of sedation the Propofol infusion should be titrated until the desired level of sedation is achieved. 5 mg/kg body weight/h will be required. The infusion may be supplemented by bolus injections of 10 to 20 mg (1 to 2 ml Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion) if a deeper level of sedation is rapidly required.

In patients older than 55 years and in patients of ASA classification III and IV the rate of administration and dosage may need to be reduced. If lower doses are needed, Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion can be used as an alternative.

4). In these patients the use of Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion is recommended. Induction of anaesthesia For induction of anaesthesia Propofol should be titrated slowly until clinical signs show the onset of anaesthesia.

The dose should be adjusted according to age and/or body weight. 5 mg/kg body weight Propofol for induction of anaesthesia. 5 – 4 mg/kg body weight). Maintenance of general anaesthesia Anaesthesia can be maintained by administering Propofol by infusion to maintain the depth of anaesthesia required.

The required rate of administration varies considerably between patients but rates in the region of 9 – 15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, dose […]

8. The infusion system should be rinsed before administration of muscle relaxants like atracurium and mivacurium when using the same infusion system for Propofol. Duration of administration Propofol can be administered for a maximum of 7 days.

4 Special warnings and precautions for use Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in intensive Care). Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times.

Propofol should not be administered by the person conducting the diagnostic or surgical procedure. Abuse of, and dependence on propofol, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.

When Propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation. During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedications and other agents.

As with other sedative agents, when Propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site. An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol.

Very rarely the use of propofol may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness.

Although recovery is spontaneous, appropriate care of an unconscious patient should be administered. Propofol induced impairment is not generally detectable beyond 12 hours. ) As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.

Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce Propofol clearance. Propofol lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole.

The intravenous administration of an anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate or when Propofol is used in conjunction with other agents likely to cause a bradycardia.

When Propofol is administered to an epileptic patient, there may be a risk of convulsion. Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.

Use of Propofol is not recommended with electroconvulsive therapy. Paediatric population The use of Propofol is not recommended in newborn infants as this patient population has not been fully investigated. 2) indicate that clearance is considerably reduced in neonates and has a very high inter-individual variability.

Relative overdose could occur on administering doses recommended for older children and result in severe cardiovascular depression. Propofol 20 mg/ml (2%) Emulsion for Injection/Infusion is not recommended for use in children < 3 years of age due to difficulty in titrating small volumes.

3). Advisory statements concerning Intensive Care Unit management Use of propofol emulsion infusions for ICU sedation has been associated with a constellation of metabolic derangements and organ system failures that may result in death.

Reports have been received of combinations of the following:

Metabolic acidosis, Rhabdomyolysis, Hyperkalaemia, Hepatomegaly, Renal failure, Hyperlipidaemia, Cardiac arrhythmia, Brugada-type ECG (elevated ST-segment and coved T-wave) and rapidly progressive Cardiac failure usually unresponsive to inotropic supportive treatment.

Combinations of these events have been referred to as the Propofol infusion syndrome. These events were mostly seen in patients with serious head injuries and children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.

The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or Propofol (usually at dose rates greater than 4mg/kg/h for more than 48 hours).

Prescribers should be alert to these events in patients with the above risk factors and immediately discontinue […]

Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in intensive Care). Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times.

Propofol should not be administered by the person conducting the diagnostic or surgical procedure. Abuse of, and dependence on propofol, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.

When Propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation. During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedications and other agents.

As with other sedative agents, when Propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site. An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol.

Very rarely the use of propofol may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness.

Although recovery is spontaneous, appropriate care of an unconscious patient should be administered. Propofol induced impairment is not generally detectable beyond 12 hours. ) As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.

Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce Propofol clearance. Propofol lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole.

The intravenous administration of an anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate or when Propofol is used in conjunction with other agents likely to cause a bradycardia.

When Propofol is administered to an epileptic patient, there may be a risk of convulsion. Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.

Use of Propofol is not recommended with electroconvulsive therapy. Paediatric population The use of Propofol is not recommended in newborn infants as this patient population has not been fully investigated. 2) indicate that clearance is considerably reduced in neonates and has a very high inter-individual variability.

Relative overdose could occur on administering doses recommended for older children and result in severe cardiovascular depression. Propofol 20 mg/ml (2%) Emulsion for Injection/Infusion is not recommended for use in children < 3 years of age due to difficulty in titrating small volumes.

3). Advisory statements concerning Intensive Care Unit management Use of propofol emulsion infusions for ICU sedation has been associated with a constellation of metabolic derangements and organ system failures that may result in death.

Reports have been received of combinations of the following:

Metabolic acidosis, Rhabdomyolysis, Hyperkalaemia, Hepatomegaly, Renal failure, Hyperlipidaemia, Cardiac arrhythmia, Brugada-type ECG (elevated ST-segment and coved T-wave) and rapidly progressive Cardiac failure usually unresponsive to inotropic supportive treatment.

Combinations of these events have been referred to as the Propofol infusion syndrome. These events were mostly seen in patients with serious head injuries and children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.

The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or Propofol (usually at dose rates greater than 4mg/kg/h for more than 48 hours).

Prescribers should be alert to these events in patients with the above risk factors and immediately discontinue Propofol when the above signs develop. All sedative and therapeutic agents used in the intensive care unit (ICU), should be titrated to maintain optimal oxygen delivery and haemodynamic parameters.

Patients with raised intra-cranial pressure (ICP) should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications. Treating physicians are reminded if possible not to exceed the dosage of 4 mg/kg/h.

Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously. It is recommended that blood […]

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