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

Postoperative Pain Clinical Trial

Official title:

The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-label, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04947345
• Other study ID #: 20-JS-2814
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2021
• Source: Peking Union Medical College Hospital
• Contact: Longxiang Su, M.D.
• Phone: +8615652797257
• Email: slx77[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: September 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria

• Meet criteria of enhanced recovery after surgery (ERAS);

• Mechanical ventilated when enrolled and have estimation of more than 10 hours of mechanical ventilation in ICU

• Aged between 18-75 years old AND 18kg/m2 = BMI = 30 kg/m2;

• Clearly know the purpose and objective of this clinical study and voluntarily enrolled.

Criteria of ERAS: (1) without dysfunction of nervous system or Glasgow Coma Score > 12; (2) a satisfied glucose level (random blood glucose<11.1mmol/L during screening stage) for diabetes mellitus patients; (3) Without acute coronary syndrome in recent 6 months; (4) Without bradycardia and third-degree atrioventricular block (except for patients with pacemaker) during screening stage; (5) systolic blood pressure>90mmHg with no usage of vasoactive agent during screening stage; (6) without mental illness (schizophrenia, depressive disorder), cognitive dysfunction (identified by MMSE), epilepsy, history of abuse of psychotropic or anesthesia medication; (7) without disorder of coagulation function (PT/INR/APTT > 1.5×upper limit), bleeding tendency (active peptic ulcer), under treatment of thrombolysis and anticoagulant; (8) without disorder of liver function (ALT/AST > 2×upper limit and total bilirubin>1.5×upper limit); (9) without disorder of renal function (Creatine or BUN/Urea>1.5×upper limit); without dialysis patients.

Exclusion criteria

• Allergy to component of Remimazolam besylate for injection;

• Woman in gestation and lactation period;

• Enrolled in other clinical trails in recent 3 months;

• Other circumstance that identified by researchers that do not suitable for this clinical trial.

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Remimazolam Besylate
Remimazolam Besylate are used as sedatives for subjects in this arm.
• Propofol
Propofol are used as sedatives for subjects in this arm.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Yichang Humanwell Pharmaceutical Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction rate of sedation	(number of subjects that meets satisfied RASS score under prescribed dose of sedative agents during study / total number of subjects) ×100%	24 hours since injection of sedatives
Primary	Rate of major clinical events	(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.	48 hours since injection of sedatives
Secondary	incidence of delirium	(subjects with delirium / total number of subjects ×100%) by 12h and 24h after entering ICU	48 hours since injection of sedatives
Secondary	Time to weaning and extubation	Time to weaning and extubation	48 hours since injection of sedatives
Secondary	Difficulty of nursing	By Barthel index assessment	48 hours since injection of sedatives
Secondary	28-days survival	(number of subjects that alive in 28-days since ICU entry/ total number of subjects) ×100%	28 days since injection of sedatives
Secondary	incidence of rescue therapy in experimental group	(number of subjects that receive rescue therapy in experimental group/ total number of subjects) ×100%	24 hours since injection of sedatives