Remifentanil in spinal fusion, IV opioid, remi for neuro

Indication, Boxed Warning, and Important Safety Information

Indication

ULTIVA is indicated for IV administration:

As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
As an analgesic component of monitored anesthesia care in adult patients.

Important Safety Information

ULTIVA is contraindicated for epidural or intrathecal administration due to the presence of glycine in the formulation and in patients with hypersensitivity to remifentanil (eg, anaphylaxis).

ULTIVA contains remifentanil, a Schedule II controlled substance. Because opioids are sought by drug abusers and people with addiction disorders, employ strategies to reduce the risks such as proper storage and control practices.

Serious, life-threatening, or fatal respiratory depression has been reported with opioids. ULTIVA should be administered only by persons specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids. Monitor patients closely, particularly during initiation and titration. Resuscitative and intubation equipment, oxygen, and opioid antagonists must be readily available. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA by 50% or by temporarily discontinuing the infusion.

Hypotension, profound sedation, respiratory depression, coma, and death may result from the concomitant use of ULTIVA with benzodiazepines or other CNS depressants. Patients should be advised to avoid alcohol for 24 hours after surgery.

A potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue ULTIVA if serotonin syndrome is suspected.

Continuous infusions of ULTIVA should be administered only by an infusion device. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Discontinuation of ULTIVA should be preceded by the establishment of adequate postoperative analgesia.

IV tubing must be cleared to remove residual ULTIVA, which has been associated with respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.

Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min..

ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products.

Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs. Monitor heart rate during dosage initiation and titration.

Hypotension has been reported with ULTIVA and is responsive to decreases in administration, or to IV fluid or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Monitor blood pressure during dosage initiation and titration.

Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤75 mcg/kg/min.

Monitor for sedation and respiratory depression in patients susceptible to the intracranial effects of carbon dioxide retention.

Standard monitoring of patients should be maintained in the postoperative period to ensure adequate recovery without stimulation.

Most common adverse reactions (incidence ≥1%) were respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity.

Please see Full Prescribing Information, including Boxed WARNING.

*Remifentanil is commonly referred to as Remi by anesthesia providers.

Why ULTIVA

Rapid response

To help manage intraoperative hemodynamics and pain¹
— In premedicated patients undergoing anesthesia, 1-minute infusions of
<2 mcg/kg of Remi* cause dose-dependent hypotension and bradycardia. When appropriate, bradycardia and hypotension can be reversed by reduction of the rate of infusion of Remi or the dose of concurrent anesthetics, or by the administration of fluids or vasopressors.¹

Flexible assessment

Provides quick emergence for neurological assessment^1,3
— Due to the rapid offset of action of Remi, no residual analgesic activity will be present within 5 to 10 minutes after discontinuation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, alternative analgesics should be administered prior to discontinuation of Remi. The choice of analgesic should be appropriate for the patient's surgical procedure and the level of follow-up care¹
Helps facilitate monitoring of SSEPs and MEPs^3,5

Added characteristics of ULTIVA

Effective analgesia with less suppressive effects on MEPs than fentanyl, alfentanil, sufentanil, propofol, and thiopental^1,5
Rapid response to dose adjustment for rapid transition to a wake-up test^1,2
— Continuous infusions of Remi should be administered only by an infusion device. The injection site should be close to the venous cannula and all IV tubing should be cleared at the time of discontinuation of infusion. Interruption of an infusion of Remi will result in rapid offset of effect¹
Rapid recovery after discontinuation with no accumulation regardless of infusion duration¹
Well-established hemodynamic profile¹

Remifentanil is commonly referred to as Remi by anesthesia providers.

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Case study and anesthesia plans

Spinal fusion case study

45-year-old female

5'7'', 74 kg (163 lb)

BMI 25.6 kg/m²

Comorbidity

Hypertension

History of intraoperative awareness

History of severe postoperative nausea and vomiting (PONV) with morphine

This case study is for illustrative and educational purposes only. The dosing regimen is specific to this case study and other regimens may vary depending on patient and procedure. Any use of this product is subject to the judgment of the practitioner in each case. Please consult the full Prescribing Information in the use of this product.

Intraoperative and recovery timeline

Goal: predictable control

Characteristics of ULTIVA in spinal fusion include:

Predictable control:
spinal fusion^1-4

Why ULTIVA

Spinal fusion case study

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