A drug Cisatracurium bezylate, the solution for intravenous administration does not contain antimicrobial preservatives and is intended for administration to one patient.
Bolus intravenous (iv)
Adults
Intubation of the trachea
The recommended dose of Cisatracurium besylate for intubation of the trachea in adults is 0.15 mg / kg, which is administered within 5-10 seconds and provides optimal conditions for intubation of the trachea during 120 s after injection.
With the introduction of higher doses of the drug, neuromuscular blockade occurs more quickly. The table shows the average pharmacodynamic indices of cisatracurium bezylate when administered at doses of 0.1 to 0.4 mg / kg to healthy adult volunteers against opioid anesthesia (thiopental sodium, fentanyl and midazolam) or anesthesia with propofol.
The mean values of the data on pharmacodynamics within the limits of the average doses of cisatracurium bezylate
Initial dose of cisatracurium bezylate for intravenous administration, mg / kg | Type of anesthesin | Time to 90% suppression of T1 *), min | Time before the maximum suppression T1 *), min | Time to 25% spontaneous recovery of T1 *), min |
0,1 | Opioid | 3,4 | 4,8 | 45 |
0,15 | Propofol | 2,6 | 3,5 | 55 |
0,2 | Opioid | 2,4 | 2,9 | 65 |
0,4 | Opioid | 1,5 | 1,9 | 91 |
*)T1 is a single contraction of the muscle that leads the thumb of the hand, as well as its first contraction in response to a series of four pulses with supramaximal electrical stimulation of the ulnar nerve.
Enflurane or isoflurane can extend the duration of the blockade caused by the initial dose of the drug by 15% Cisatracurium bezylate.
Maintenance dose
The duration of neuromuscular blockade can be increased by the introduction of maintenance doses of Cisatracurium bezilate. Thus, during anesthesia with opioids or propofol cisatracurium bezylate in a dose of 0.03 mg / kg prolongs the neuromuscular blockade by approximately 20 minutes. However, the subsequent administration of maintenance doses does not lead to a progressive lengthening of the blockade.
Spontaneous recovery
After the spontaneous recovery of neuromuscular conduction has begun, its rate does not depend on the administered dose of Cisatracurium bezilate. During anesthesia with opioids or propofol, the mean recovery time for neuromuscular conduction from 25% to 75% and from 5% to 95% is approximately 13 minutes and 30 minutes, respectively.
Reversibility
Cisatracuria induced by bezelate neuromuscular blockade is easily eliminated by standard doses of cholinesterase inhibitors. After the introduction of cholinesterase inhibitor on average with a 10% T1 reduction in conductivity, the average conduction recovery time from 25% to 75% and until complete recovery (T4: T1 ≥ 0.7) is approximately 4 minutes and 9 minutes, respectively.
Children aged 1 month to 12 years
Intubation of the trachea
As in adults, the initial dose of Cisatracuria besylate for intubation of the trachea in children is 0.15 mg / kg, which is given intravenously for 5-10 seconds and creates optimal conditions for intubation of the trachea within 120 seconds after the injection. The pharmacodynamic data for these doses are presented in the tables below. Based on pharmacodynamic data to provide a neuromuscular blockade of a shorter duration, the initial dose of Cisatracurium bezilate 0.1 mg / kg is recommended; in this case, similar conditions for intubation of the trachea are created at 120-150 s after the administration of the drug. Possibility of using Cisatracuria besylate for intubation in children with a class III-IV by ASA not studied.
Data on the use of cisatracurium bezilate in children younger 2 years in the conduct of long or large operations are limited.
The duration of neuromuscular blockade against a background of Cisatracurium bezilate in children aged from 1 months. before 12 years decrease, and its spontaneous recovery occurs faster in comparison with adults with the same type of anesthesia. There are insignificant differences in pharmacodynamic parameters of cisatracurium bezilate in children aged 1 before 11 months. from those in children aged from 1 before 12 years.
Pharmacodynamic parameters cisatracurium bezylate for children aged 1 to 11 months. and from 1 years before 12 years are presented in the tables.
Children aged from 1 to 11 months.
Initial dose of cisatracurium bezylate for intravenous administration, mg / kg | Type of anesthesia | Time the onset of 90% suppression of T1, min | Time before maximum suppression T1, min | Time to 25% spontaneous recovery T1, min |
0,15 | Halothane | 1,4 | 2,0 | 52 |
0,15 | Opioid | 1,4 | 1,9 | 47 |
Children aged 1 to 12 years
Initial dose of cisatracurium bezylate for intravenous administration, mg / kg | Type of anesthesia | Time of onset of 90% suppression of T1, min | Time before maximum suppression T1, min | Time to 25% spontaneous recovery T1, min |
0,15 | Halothane | 2,3 | 3,0 | 43 |
0,15 | Opioid | 2,6 | 3,6 | 38 |
When using Tsisatrakuria besylate, doses less than 0.15 mg / kg may not be used for intubation. Pharmacodynamic parameters for doses of 0.08 and 0.1 mg / kg in children aged 2 to 12 years are presented in the table below.
Children from 2 to 12 years old
Initial dose of cisatracurium bezylate for intravenous administration, mg / kg | Type of anesthesin | Time of onset of 90% suppression of T1, min | Time before maximum suppression T1, min | Time to 25% spontaneous recovery T1, min |
0,08 | Halothane | 1,7 | 2,5 | 31 |
0,1 | Opioid | 1,7 | 2,8 | 28 |
Halothane may prolong the duration of the neuromuscular blockade caused by cisatracurium bezylate by no more than 20%. Information on the use of cisatracurium bezilate in children during anesthesia with isoflurane or enflurane is not available, but it can be expected that these inhaled anesthetics can also increase the duration of neuromuscular blockade caused by the drug by no more than 20%.
Supportive dose (children aged 2 to 12 years)
The duration of neuromuscular blockade can be increased by the introduction of cisatracurium bezylate in maintenance doses. With halothane anesthesia, cisatracurium bezylate in a dose 0,02 mg / kg increases the duration of neuromuscular blockade by approximately 9 minutes. However, the subsequent administration of maintenance doses does not lead to a progressive lengthening of the blockade.
The data is not enough to give specific recommendations but the selection of a maintenance dose in children aged 2 years. However, very limited data from clinical trials in children before 2 years show that a maintenance dose of 0.03 mg / kg can prolong the clinically effective neuromuscular blockade up to 25 min with opioid anesthesia.
Spontaneous recovery
After the spontaneous recovery of neuromuscular conduction has begun, its rate does not depend on the administration of the dose of the drug Cisatracurium bezylate. During anesthesia with opioids or halothane, the mean recovery time of conductivity from 25% to 75% and from 5% to 95% is approximately 11 minutes and 28 minutes, respectively.
Reversibility
Cisatracurium-induced bezelate neuromuscular blockade is easily eliminated by standard doses of cholinesterase inhibitors. The average conduction recovery time from 25% to 75% and until complete recovery (T4 coefficient: T1 ≥ 0.7) after the administration of cholinesterase inhibitor, on average at 13%, T1 conduction recovery is approximately 2 min and 5 min, respectively.
Infusion introduction
Adults and children aged 2 months to 12 years
To maintain neuromuscular blockade Cisatracurium bezylate can be administered intravenously drip. To restore the blockade of T1 at 89-99% after the appearance of signs of spontaneous recovery of neuromuscular conduction, an initial infusion rate of 3 μg / kg / min (0.18 mg / kg / h) is recommended. After the initial stabilization of the neuromuscular blockade to maintain it at this level, the majority of patients have sufficient infusion rate within 1-2 μg / kg / min (0.06-0.12 mg / kg / h).
During anesthesia with isoflurane or enflurane, a decrease in the rate of infusion of Cisatracurium bezilate by 40% may be required.
The rate of infusion depends on the concentration of cisatracurium bezylate in the infusion solution, the required depth of the neuromuscular blockade and the patient's body weight.
The table contains recommendations for the introduction of undiluted Cisatracurium bezylate solution for intravenous administration, 2 mg / ml.
Infusion rate of Cisatracuria bezilate, solution for iv administration 2 mg / ml
see Fig. 1.
Continuous infusion Cisatracuria bezilata with a constant speed is not accompanied by a progressive increase or weakening of the neuromuscular blockade.
After cessaturation of the infusion of cisatracuria bezilata, the spontaneous recovery of neuromuscular conduction occurs at a rate comparable to that after a single bolus administration of the drug.
Despite the fact that the introduction of Cisatracuria besylate in the form of infusion was not specifically studied in children under the age of 2 years, by analogy with doses for bolus administration, it can be assumed that the infusion rate in this age group should be the same as in older children.
Special patient groups
Newborns under the age of 1 month.
There is no data on the use of cisatracurium bezilate in children under 1 month of age, therefore, it is not possible to give recommendations on the dosage of the drug in this age group. Elderly patients
Dose adjustments in elderly patients are not required. Pharmacodynamics of cisatracurium besylate in them is similar to that of young patients, but the effect of Cisatracurium bezilate, like other muscle relaxants, may begin somewhat later.
Patients with impaired renal function
Dose adjustments in patients with renal insufficiency are not required. Pharmacodynamics of cisatracurium besylate in them is similar to that of patients with a normal function of the nights, but the effect of Cisatracurium bezilate may begin somewhat later.
Patients with impaired hepatic function
Dose adjustments in patients with terminal liver failure are not required. Pharmacodynamics of cisatracurium besylate in them is similar to that in patients with normal liver function, however, the effect of Cisatracurium bezilate may begin somewhat earlier.
Patients with diseases of the cardiovascular system
The rapid administration of cisatracurium bezilate (within 5-10 s) as a bolus in any studied dose (up to 0.4 mg / kg inclusive - 8 x ED95) to patients with severe cardiovascular diseases (I-III functional class for NYHA, subjected to aortocoronary shunting) is not accompanied by clinically significant reactions from the cardiovascular system.
Data on the use of Cisatracuria besylate in children undergoing cardiosurgery are not available.
Application in ICU
Adult patients in the ICU drug Cisatracurium bezylate can be injected intravenously (as a bolus) and / or drip (as an infusion).
For adult patients in ICU, the recommended initial infusion rate of Cisatracuria bezilate is 3 μg / kg / min (0.18 mg / kg / h). In different patients, the dose required varies over a wide range and may, with time, increase or decrease. In clinical studies, the average infusion rate was 3 μg / kg / min (0.5-10.2 μg / kg / min or 0.03-0.6 mg / kg / h).
The mean time to complete spontaneous recovery of conductivity after a prolonged (up to 6 days) infusion of Cisatracuria besylate in patients in ICU is approximately 50 min.
The rate of recovery of neuromuscular conduction after completion of infusion of Cisatracuria besylate in patients in ICU does not depend on its duration.
Use in patients undergoing cardiac surgery under hypothermia
There is no data on the use of the drug Cisatracurium bezylate during cardiac surgery under hypothermia (25-28 ° C). As with other muscle relaxants, the rate of infusion necessary to maintain adequate surgical muscle relaxation under these conditions is expected to be significantly reduced.
Monitoring
As with other muscle relaxants, when using Tsisatrakurium besylate for individual dosing, monitoring of neuromuscular function is recommended.
Instructions for use of the solution
Since the preparation does not contain antimicrobial preservatives, it should be diluted immediately before use, the diluted solution must be injected immediately, and the unused drug solution should be disposed of. Cisatracurium bezylate is chemically unstable when diluted in Ringer's solution.
With the introduction of other drugs through the same needle or cannula through which Cisatracuria bezilate was administered, it is recommended that the needle and cannula be washed with a sufficient amount of a compatible solution for intravenous administration, for example with a solution of 0.9% sodium chloride.
Cisatracurium bezylate is stable only in acidic solutions, therefore it should not be mixed in one syringe or administered simultaneously through a single needle with alkaline solutions, for example, with sodium thiopental.
If a peripheral vein of small caliber is used for the administration of Cisatracuria besylate, after administration, it should be washed with a compatible solution for intravenous administration, for example with a solution of 0.9% sodium chloride.