Tegileridine Fumarate lnjection
DrugTegileridine Fumarate lnjection; low dose
NCT Number: NCT07372924
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2
Zhongshan Hospital, Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tegileridine Fumarate lnjection; low dose
Remifentanil Hydrochloride for Injection
Time frame: within 3 days after administration of research drug
Time frame: within 3 days after administration of research drug
Time frame: within 3 days after administration of research drug
Time frame: within 3 days after administration of research drug
Time frame: within 3 days after administration of research drug
Time frame: within 3 days after discontinuation of research drug
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: From research drug administration to actual extubation , up to 72 hours
Time frame: From discontinuation of research drug to actual extubation , up to 72 hours
Contact information is provided by the study sponsor or research team.
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase II, Multicenter, Randomized, Single-Blind, Dose Exploration, Positive Comparator Study to Evaluate the Efficacy and Safety of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.