Efficacy and Safety Studies of Oliceridine Fumarate

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

292

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Analgesia
Interventions
DRUG

Oliceridine Fumarate

After subjects were enrolled, the original sedative and analgesic drugs were discontinued, and a starting dose of 6ug/kg/h of oliceridine fumarate was continuously pumped, and the time of oliceridine fumarate initiation was recorded as T0. Subjects were assessed for sedation using the RASS score, and for analgesia using the CPOT score. Waiting for the original sedative-analgesic drug to elute until CPOT ≥ 3 and RASS \> 0. Adjust the infusion rate of oliceridine fumarate according to the CPOT score (recommended to be adjusted by 2ug/kg/h, the range of adjustment is 2-20 ug /kg/h, and the maximum infusion rate is not more than 20 ug /kg/h) until the analgesic score of the subject is CPOT\<3. The interval between two trial drug rate adjustments should be ≧5 min, and a CPOT score should be performed before each drug adjustment.

DRUG

Remifentanil

After subjects were enrolled, the original sedative and analgesic drugs were discontinued, and remifentanil was continuously pumped at a starting dose of 1.5ug/kg/h. The time of remifentanil initiation was recorded as T0. Subjects were assessed for sedation using the RASS score and analgesia using the CPOT score. We waited for the original sedative-analgesic drugs to elute until CPOT ≥ 3 and RASS \> 0. The infusion rate of remifentanil was adjusted according to the CPOT score (1.5ug/kg/h is recommended, the range of adjustment is 1.5\~12μg/kg/h, and the maximum infusion rate is not more than 12μg/kg/h) until the subject's analgesic score of CPOT\<3, and the interval between the two experimental rate adjustments of the drug should be ≧5min, and the CPOT score should be performed before each adjustment of the drug. The CPOT score should be performed before each drug adjustment.

All Listed Sponsors
lead

Chun Pan

OTHER

NCT06454292 - Efficacy and Safety Studies of Oliceridine Fumarate | Biotech Hunter | Biotech Hunter