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

NCT04947345 | Unknown Phase 3 DMC

• 1 other identifier: 20-JS-2814
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Analgesia; Postoperative Pain

Keywords

sedative; Remimazolam Besylate; postoperative sedation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• incidence of delirium

  48 hours since injection of sedatives

• Time to weaning and extubation

  48 hours since injection of sedatives

• Difficulty of nursing

  48 hours since injection of sedatives

• 28-days survival

  28 days since injection of sedatives

• incidence of rescue therapy in experimental group

  24 hours since injection of sedatives

Study Arms (2)

Experimental group: Remimazolam Besylate

EXPERIMENTAL

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.

Drug: Remimazolam Besylate

Positive control group: Propofol

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

Remimazolam Besylate DRUG

Remimazolam Besylate are used as sedatives for subjects in this arm.

Experimental group: Remimazolam Besylate

Propofol DRUG

Propofol are used as sedatives for subjects in this arm.

Positive control group: Propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Yichang Humanwell Pharmaceutical Co., Ltd., China: collaborator

Related Publications (1)

• Liu S, Su L, Zhang B, He H, Li Z, Li Q, Wang Q, Smith F, Long Y. 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. Front Med (Lausanne). 2021 Nov 5;8:735473. doi: 10.3389/fmed.2021.735473. eCollection 2021.

  PMID: 34805204 DERIVED

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Propofol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Longxiang Su, M.D.

CONTACT

+8615652797257; slx77@163.com

Shengjun Liu, M.D.

CONTACT

+8618911952413; liushengjun100@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a open label clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 1, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-06