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Label indication ULTIVA is indicated for intravenous (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.
Remifentanil · 1 trial · 1 indication
Positive response is defined by the presence of at least one of below listed conditions: Heart rate increased \>20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for \>1 minute); Systolic blood pressure increased \>20% above baseline (that is measured under stable hemodynamics after intubation, and 1-5 minutes before the planned start of skin incision) for \>1 minute; Gross movement, swallowing, eye opening (if there are patches on the eyes, this assessment might be not evaluated) or grimacing and sweating, lachrymation or mydriasis.
| Arm | Type | Description |
|---|---|---|
| Remifentanil (0.25 µg/kg/min) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Remifentanil | DRUG | After intubation, continuous intravenous infusion of remifentanil (0.25 µg/kg/min) is started, while anesthesia is maintained with inhaled or intravenous anesthetics. In cases where sedation by general anesthetics and analgesia by lidocaine does not seem to provide a sufficient means of analgesia at the time of intubation, remifentanil may be used, beginning before intubation. The rate of infusion may be adjusted while monitoring the subject's general condition in 25% to 100% increments or in 25% to 50% decrements every 2 to 5 minutes, but should not exceed 1.3 µg/kg/min. |
Inclusion Criteria: * Participants scheduled to receive surgery under general anesthesia, necessitating airway securing with tracheal intubation and analgesia with opioid analgesics * American Society of Anesthesiologists (ASA) Physical Status Classification is I or II at the time of operation plan...
Remifentanil is a small molecule anesthetic agent developed by Johnson & Johnson (ticker JNJ) for use in anesthesia. It is an opioid-based medicine studied for use during general anesthesia, including in pediatric participants. It is given as part of anesthetic care rather than as a take-home treatment.
Remifentanil targets OPRM1, the mu opioid receptor, and acts as an agonist at that receptor. By activating OPRM1, it produces opioid-mediated analgesic and anesthetic effects. This receptor target places remifentanil in the opioid agonist class of small molecule agents used in anesthesia.
Remifentanil is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor associated with the clinical development of the drug, including the Phase 3 study conducted in Japan in pediatric participants undergoing general anesthesia.
Remifentanil has been studied in Phase 3 clinical development. It is an investigational agent in the context of the trial record, and the Phase 3 study of remifentanil hydrochloride in pediatric general anesthesia has been completed. The program includes one completed trial with no active trials currently listed.
Remifentanil has been evaluated in the Phase 3 trial NCT01998165, titled A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised. That trial enrolled 80 participants in Japan, included ages one year and older, and has been completed.
Yes, Ultiva is another name for remifentanil hydrochloride. The Phase 3 trial NCT01998165 refers to the drug as Ultiva (Remifentanil Hydrochloride), so searches for either name point to the same Johnson & Johnson anesthetic agent studied in pediatric general anesthesia.