Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01998165 | A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised | PHASE3 | COMPLETED | 80 | — | — | Nov 1, 2013 | Nov 1, 2014 | Nov 16, 2015 | 9 | Japan |
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 | NA | Undisclosed |