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Remifentanil should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation.
As mechanically ventilated, intensive care patients were not studied beyond three days, no evidence of safety and efficacy for longer treatment has been established. Therefore, a longer usage is not recommended in intensive care patients.
Rapid offset of action/transition to alternative analgesia: Due to the very rapid offset of action of remifentanil, patients may emerge rapidly from anaesthesia and no residual opioid activity will be present within 5-10 minutes after the discontinuation of remifentanil. During administration of remifentanil as a μ-opioid agonists the potential for the development of tolerance and hyperalgesia should be paid attention to. Therefore, prior to discontinuation of remifentanil, patients must be given alternative analgesic and sedative agents at a sufficient time in advance to allow the therapeutic effects of these agents to become established and to prevent hyperalgesia and concomitant haemodynamic changes.
For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of remifentanil. Sufficient time must be allowed to reach the maximum effect of the longer acting analgesic. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of post-operative care. When other opioid agents are administered as part of the regimen for transition to alternative analgesia, the benefit of providing adequate post-operative analgesia must always be balanced against the potential risk of respiratory depression with these agents.
Discontinuation of treatment: Symptoms following withdrawal of remifentanil including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days. Where reported, re-introduction and tapering of the infusion has been beneficial. The use of Remifentanil in mechanically ventilated intensive care patients is not recommended for duration of treatment greater than 3 days.
Muscle rigidity- prevention and management: At the doses recommended muscle rigidity may occur. As with other opioids, the incidence of muscle rigidity is related to the dose and rate of administration. Therefore, bolus injections should be administered over not less than 30 seconds.
Muscle rigidity induced by remifentanil must be treated in the context of the patient's clinical condition with appropriate supporting measures including ventilatory support. Excessive muscle rigidity occurring during the induction of anaesthesia should be treated by the administration of a neuromuscular blocking agent and/or additional hypnotic agents. Muscle rigidity seen during the use of remifentanil as an analgesic may be treated by stopping or decreasing the rate of administration of remifentanil. Resolution of muscle rigidity after discontinuing the infusion of remifentanil occurs within minutes. Alternatively, a μ-opioid antagonist may be administered; however this may reverse or attenuate the analgesic effect of remifentanil.
Respiratory depression- preventive measures and treatment: As with all potent opioids, profound analgesia is accompanied by marked respiratory depression. Therefore, remifentanil should only be used in areas where facilities for monitoring and dealing with respiratory depression are available. Special care should be taken in patients with impaired lung function and with severe hepatic impairment. These patients may be slightly more sensitive to the respiratory depressant effects of remifentanil. These patients should be closely monitored and the dose of remifentanil titrated to individual patient need.
The appearance of respiratory depression should be managed appropriately, including decreasing the rate of infusion by 50%, or by a temporary discontinuation of the infusion. Unlike other fentanyl analogues, remifentanil has not been shown to cause recurrent respiratory depression even after prolonged administration. However in the presence of confounding factors (e.g. inadvertent administration of bolus doses (see section as follows) and administration of concomitant longer acting opioids), respiratory depression occurring up to 50 minutes after discontinuation of infusion has been reported. As many factors may affect post-operative recovery, it is important to ensure that full consciousness and adequate spontaneous ventilation are achieved before the patient is discharged from the recovery area.
Cardiovascular effects: Hypotension and bradycardia can give rise to asystole and cardiac arrest (see Adverse Reactions and Interactions) may be managed by reducing the rate of infusion of remifentanil or the dose of concurrent anaesthetics or by using IV fluids, vasopressor or anticholinergic agents as appropriate.
Debilitated, hypovolaemic, and elderly patients may be more sensitive to the cardiovascular effects of remifentanil.
Inadvertent administration: A sufficient amount of remifentanil may be present in the dead space of the IV line and/or cannula to cause respiratory depression, apnoea and/or muscle rigidity if the line is flushed with IV fluids or other drugs. This may be avoided by administering remifentanil into a fast flowing IV line or via a dedicated IV line which is removed when remifentanil is discontinued.
Neonates/infants: There is limited data available on use in neonates/infants under 1 year of age (see Pharmacology: Pharmacodynamics under Actions and Dosage & Administration).
Drug abuse: As with other opioids remifentanil may produce dependency.
Effects on ability to drive and use machines: Remifentanil has major influence on the ability to drive and use machines. The physician has to decide when these activities may be resumed.
If an early discharge is envisaged after application of remifentanil, following treatment using anaesthetic agents, patients should be advised not to drive or operate machinery. It is advisable that the patient is accompanied when returning home and that alcoholic drink is avoided.
