A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Study population

Groups and cohorts

• General anesthesia cohort

  Drug: Remimazolam Tosilate for Injection

• Bronchoscopy sedation cohort

  Drug: Remimazolam Tosilate for Injection

Interventions

• DrugRemimazolam Tosilate for Injection

  Remimazolam Tosilate for Injection

Primary outcomes

1. Adverse events

   Use adverse event record form,Refer to version 5.0 of the NCI-CTCAE

   Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

Secondary outcomes

1. Serious adverse events

   Refer to SAE definition standards

   Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

2. Adverse drug reactions

   By evaluating the association of adverse events with drugs

   Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

3. Injection pain

   Refer to the NCI-CTCAE \<5.0\> grading criteria for drug injection site reactions

   Time frame: Within 3 days of receiving General anesthesia and bronchoscopy sedation

Individual participant data

Plan to share: Undecided