Tracheal Intubation

Active Ingredient: Cisatracurium

Indication for Cisatracurium

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

For this indication, competent medicine agencies globally authorize below treatments:

0.15mg/kg

For:

Dosage regimens

Intravenous, 0.15 milligrams cisatracurium per kilogram of body weight, one dose.

Detailed description

The recommended intubation dose of cisatracurium for adults is 0.15mg/kg (body weight). This dose produced good to excellent conditions for tracheal intubation 120 seconds after administration of cisatracurium, following induction of anaesthesia with propofol.

Higher doses will shorten the time to onset of neuromuscular block.

Table 1 summarises mean pharmacodynamic data when cisatracurium was administered at doses of 0.1 to 0.4mg/kg (body weight) to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia.

Initial cisatracurium Dose mg/kg (body weight)Anaesthetic BackgroundTime to 90% T1* Suppression (min)Time to Maximum T1* Suppression (min)Time to 25% Spontaneous T1* Recovery(min)
0.1Opioid3.44.845
0.15Propofol2.63.555
0.2Opioid2.42.965
0.4Opioid1.51.991

* T1 Single twitch response as well as the first component of the Train-of-four response of the adductor pollicis muscle following supramaximal electrical stimulation of the ulnar nerve.

Enflurane or isoflurane anaesthesia may extend the clinically effective duration of an initial dose of cisatracurium by as much as 15%.

Maintenance

Neuromuscular block can be extended with maintenance doses of cisatracurium. A dose of 0.03 mg/kg (body weight) provides approximately 20 minutes of additional clinically effective neuromuscular block during opioid or propofol anaesthesia.

Consecutive maintenance doses do not result in progressive prolongation of effect.

Spontaneous Recovery

Once spontaneous recovery from neuromuscular block is underway, the rate is independent of the cisatracurium dose administered. During opioid or propofol anaesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 13 and 30 minutes, respectively.

Reversal

Neuromuscular block following cisatracurium administration is readily reversible with standard doses of anticholinesterase agents. The mean times from 25 to 75% recovery and to full clinical recovery (T4:T1 ratio ≥0.7) are approximately 4 and 9 minutes respectively, following administration of the reversal agent at an average of 10% T1 recovery.

0.15 mg/kg

For:

Dosage regimens

Intravenous, 0.15 milligrams cisatracurium per kilogram of body weight, one dose.

Detailed description

Tracheal Intubation (paediatric patients aged 1 month to 12 years)

As in adults, the recommended intubation dose of cisatracurium is 0.15 mg/kg (body weight) administered rapidly over 5 to 10 seconds. This dose produces good to excellent conditions for tracheal intubation 120 seconds following injection of cisatracurium. Pharmacodynamic data for this dose are presented in the tables below.

Cisatracurium has not been studied for intubation in ASA Class III-IV paediatric patients. There are limited data on the use of cisatracurium in paediatric patients under 2 years of age undergoing prolonged or major surgery.

In paediatric patients aged 1 month to 12 years, cisatracurium has a shorter clinically effective duration and a faster spontaneous recovery profile than those observed in adults under similar anaesthetic conditions. Small differences in the pharmacodynamic profile were observed between the age ranges 1 to 11 months and 1 to 12 years which are summarised in the tables 2 and 3.

Table 2. Paediatric Patients aged 1 to 11 months:

Cisatracurium Dose mg/kg (body weight)Anaesthetic BackgroundTime to 90% Suppression (min)Time to Maximum Suppression (min)Time to 25% Spontaneous T1 Recovery (min)
0.15Halothane1.42.052
0.15Opioid1.41.947

Table 3. Paediatric Patients aged 1 to 12 years:

Cisatracurium Dose mg/kg (body weight)Anaesthetic BackgroundTime to 90% Suppression (min)Time to Maximum Suppression (min)Time to 25% Spontaneous T1 Recovery (min)
0.15Halothane2.33.043
0.15Opioid2.63.638

When cisatracurium is not required for intubation: A dose of less than 0.15mg/kg can be used. Pharmacodynamic data for doses of 0.08 and 0.1 mg/kg for paediatric patients aged 2 to 12 years are presented in the table 4:

Table 4. Paediatric patients aged 2 to 12 years:

Cisatracurium Dose mg/kg (body weight)Anaesthetic BackgroundTime to 90% Suppression (min)Time to Maximum Suppression (min)Time to 25% Spontaneous T1 Recovery (min)
0.08Halothane1.72.531
0.1Opioid1.72.828

Administration of cisatracurium following suxamethonium has not been studied in paediatric patients (see section 4.5).

Halothane may be expected to extend the clinically effective duration of a dose of cisatracurium by up to 20%. No information is available on the use of cisatracurium in children during anaesthesia with other halogenated fluorocarbon anaesthetic agents, but these agents may also be expected to extend the clinically effective duration of a dose of cisatracurium.

Maintenance (paediatric patients aged 2-12 years)

Neuromuscular block can be extended with maintenance doses of cisatracurium. In paediatric patients aged 2 to 12 years, a dose of 0.02 mg/kg (body weight) provides approximately 9 minutes of additional clinically effective neuromuscular block during halothane anaesthesia. Consecutive maintenance doses do not result in progressive prolongation of effect.

There are insufficient data to make a specific recommendation for maintenance dosing in paediatric patients under 2 years of age. However, very limited data from clinical studies in paediatric patients under 2 years of age suggest that a maintenance dose of 0.03mg/kg may extend clinically effective neuromuscular block for a period of up to 25 minutes during opioid anaesthesia.

Spontaneous Recovery

Once recovery from neuromuscular block is underway, the rate is independent of the cisatracurium dose administered. During opioid or halothane anaesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 11 and 28 minutes, respectively.

Reversal

Neuromuscular block following cisatracurium administration is readily reversible with standard doses of anti-cholinesterase agents. The mean times from 25 to 75% recovery and to full clinical recovery (T4:T1 ratio ≥ 0.7) are approximately 2 and 5 minutes respectively, following administration of the reversal agent at an average of 13% T1 recovery.

Active ingredient

Cisatracurium

Cisatracurium is an intermediate-duration, non-depolarising benzylisoquinolinium skeletal muscle relaxant. Cisatracurium binds to cholinergic receptors on the motor end-plate to antagonise the action of acetylcholine, resulting in a competitive block of neuromuscular transmission. This action is readily reversed by anti-cholinesterase agents such as neostigmine or edrophonium.

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