The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients

Phase 3

• Conditions: Analgesia; Postoperative Pain
• Interventions: Drug: Remimazolam Besylate; Drug: Propofol

• Registration Number: NCT04947345
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This trial intends to evaluate Remimazolam Besylate's availability and safety compared with propofol.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Study Start: 2021-09-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group: Remimazolam Besylate	Remimazolam Besylate	Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of Remimazolam is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.2-1 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and Remimazolam, no analgesic or sedative could be used during the experimental time period.
Positive control group: Propofol	Propofol	Patients should be given study drugs as soon as possible after entering the ICU. Syringe pump is used to administer medication. Loading dose of propofol is 0.2 mg/kg, which is administered for less than 1 min initially. Maintaining dose is 0.3-4.0 mg/kg/h. Sedative target is RASS between 0 and -2 points. Excepts for fentanyl and propofol, no analgesic or sedative could be used during the experimental time period. Rescue therapy for experimental group During the treatment of the experimental group, if the RASS cannot be maintained at 0 to -2 points at the maximum Remimazolam maintenance dose of 1 mg/kg/h, a loading dose of propofol (0.2 mg/kg) can be given intravenously. If RASS fails to satisfied after three loading doses of propofol, Remimazolam is discarded and 0.3-4.0 mg/kg/h of propofol are used as rescue therapy for experimental group.

Primary Outcome Measures

Name	Time	Method
Satisfaction rate of sedation	24 hours since injection of sedatives	(number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100%
Rate of major clinical events	48 hours since injection of sedatives	(number of subjects that suffer from major clinical events during study / total number of subjects) ×100%. Major clinical events are defined as cardiac arrest, malignant arrhythmia, new onset of shock, new onset of sepsis and respirate failure unrelated to primary illness.

Secondary Outcome Measures

Name	Time	Method
incidence of delirium	48 hours since injection of sedatives	(subjects with delirium / total number of subjects ×100%) by 12h and 24h after entering ICU
Time to weaning and extubation	48 hours since injection of sedatives	Time to weaning and extubation
Difficulty of nursing	48 hours since injection of sedatives	By Barthel index assessment
28-days survival	28 days since injection of sedatives	(number of subjects that alive in 28-days since ICU entry/ total number of subjects) ×100%
incidence of rescue therapy in experimental group	24 hours since injection of sedatives	(number of subjects that receive rescue therapy in experimental group/ total number of subjects) ×100%