The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Tegileridine Fumarate lnjection; low dose
Tegileridine Fumarate lnjection; high dose
Remifentanil Hydrochloride for Injection
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan, China
RECRUITINGRate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.
Time frame: within 3 days after administration of research drug
Percentage of time maintaining target abirritation in the entire drug administering time.
Time frame: within 3 days after administration of research drug
Percentage of subjects receiving rescue analgesic drug
Time frame: within 3 days after administration of research drug
The total dosage of rescue analgesic drug
Time frame: within 3 days after administration of research drug
Receiving the total dosage of sedation
Time frame: within 3 days after administration of research drug
Nursing Scores
The investigator will conduct an overall nursing assessment of the subject during the safety follow-up period, and the sum of each score will be calculated : (1) Overall Assessment of Adaptability to Sedation and the Intensive Care Environment, Very Easy=1, Easy =2, Fair =3, Difficult=4; (2) Overall Assessment of Adaptability to Endotracheal Intubation/Ventilation, Good=1, Fair =2,Poor=3; (3) Overall Assessment of Ease of Communication with the Patient, Very Easy=1, Easy =2, Fair =3, Difficult=4, Impossible=5; (4) Overall Assessment of Ease of Patient Care, Good=1, Fair =2,Poor=3.
Time frame: within 3 days after discontinuation of research drug
Mechanical ventilation time.
Time frame: From research drug administration to actual extubation , up to 72 hours
Extubation time
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Time frame: From discontinuation of research drug to actual extubation , up to 72 hours