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NOT YET RECRUITING
NCT06454292
PHASE4

Efficacy and Safety Studies of Oliceridine Fumarate

Sponsor: Chun Pan

View on ClinicalTrials.gov

Summary

The objective of this clinical trial is to investigate the efficacy and safety of oliceridine fumarate for analgesic treatment in mechanically ventilated subjects in the ICU. This study was conducted to answer the following questions (1) the efficacy of oliceridine fumarate for analgesic treatment in subjects with ICU mechanical ventilation (2) the safety of oliceridine fumarate for analgesic treatment in subjects with ICU mechanical ventilation. This study proposes to conduct a randomized controlled clinical trial in mechanically ventilated patients in the intensive care unit to compare the analgesic efficacy and incidence of adverse effects of two drugs, oliceridine fumarate injection and remifentanil. Subjects had an analgesic goal of CPOT \<3 points and a sedation goal of RASS -2 to 0 points. Infusion syringes of remifentanil or oliceridine fumarate were prepared by a nurse according to the weight of the subjects. Subjects were enrolled in the group and were scored for analgesia and sedation related scores. Both groups received routine ICU monitoring and appropriate treatment, which was determined by the clinician.

Official title: Efficacy and Safety Study of Oliceridine Fumarate Versus Remifentanil for Analgesic Therapy in Mechanically Ventilated Subjects in the ICU

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

292

Start Date

2024-06

Completion Date

2025-12

Last Updated

2024-06-12

Healthy Volunteers

No

Conditions

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.