Approval Probability
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Adjusted LOA
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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan, Astra-Zeneca |
| Cardinal Health, Inc. | CAH | 1 | - | Undisclosed |
| Medtronic Plc | MDT | 1 | N/A | Undisclosed |
Remifentanil is used for anesthesia. It is an investigational small molecule being developed by Johnson & Johnson for use in general anesthesia, including in pediatric patients. It is currently in Phase 3 clinical development.
Remifentanil is an opioid analgesic that works by binding to mu-opioid receptors in the brain and spinal cord. This binding produces analgesia and sedation, making it useful as an anesthetic adjunct during surgical procedures.
Remifentanil is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in anesthesia.
Remifentanil is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its safety and efficacy in pediatric patients undergoing general anesthesia.
Remifentanil has one completed Phase 3 clinical trial, identified as NCT01998165. This study evaluated the safety and efficacy of Ultiva (remifentanil hydrochloride) in 80 pediatric participants aged 1 year and older who were undergoing general anesthesia in Japan.
Yes, Remifentanil is the same as Ultiva. The clinical trial NCT01998165 refers to the drug as Ultiva (remifentanil hydrochloride), which is the brand name for remifentanil. Both names refer to the same investigational anesthetic agent.