RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery

NCT ID: NCT05606315

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2024-12-31

Brief Summary

Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU.

Detailed Description

Remimazolam besylate is a new type of ultra-short-acting benzodiazepine, showing rapid clearance and moderate distribution of pharmacokinetic changes. Remimazolam has been widely studied for programmed sedation in endoscopic procedures such as gastroenteroscopy and bronchoscopy. Remimazolam, as a short-acting sedative agent that is not metabolized by liver or kidney, can achieve rapid and reversible sedation and has the potential to shorten the duration of mechanical ventilation.

In the oral and maxillofacial surgical treatment, the use of microvascular free tissue transfer for reconstruction is one of the common operations. In order to avoid mechanical damage to the transplanted reconstructed tissue due to spontaneous movement, patients undergoing major head and neck reconstruction surgery are considered to require postoperative deep sedation for a certain period of time (RASS score required -4/-5 points). Deep sedation may cause hypotension and lead to reduced flap perfusion pressure, increasing the risk of hypoperfusion and flap necrosis, thus requiring close postoperative monitoring in the ICU.

Therefore, there is an urgent need for a sedative drug that can achieve rapid and sufficient sedation, does not inhibit breathing and can reduce the amount of patients or rapid recovery after drug withdrawal without increasing delirium. Based on the deficiencies of currently used sedatives and the potential advantages of remimazolam, we hypothesize that remimazolam can shorten the extubation time and lower the adverse reaction rate in patients with oropharyngeal cancer after mechanical ventilation sedation.

This clinical study was a randomized, multi-center, parallel-controlled, non-inferior clinical study. After signing the informed consent, participants meeting the inclusion/exclusion criteria will be randomly assigned to the treatment group (ramazolam besylate) and the control group (propofol, midazolam) in a ratio of 1:1:1, with a total of 285 participants recruited.

Conditions

Remimazolam Besylate; Sedation; ICU

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remimazolam besylate

Remimazolam besylate is a new ultra-short-acting benzodiazepine drug, which is a benzodiazepine central nervous system inhibitor. It can bind to central GABAA receptors and produce sedative effects in animal experiments. Currently, it is used in painless diagnosis and treatment sedation, colonoscopy sedation, general anesthesia, ICU sedation and local anesthesia sedation.

Group Type: EXPERIMENTAL

Remimazolam Besylate

Intervention Type: DRUG

NS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h.

propofol

Propofol, known chemically as 2, 6-diisopropyl phenol, is an organic compound with the chemical formula C12H18O and is a short-acting intravenous anesthetic used for the induction and maintenance of general anesthesia. It is often used in conjunction with epidural or spinal anesthesia, as well as with analgesics, muscle relaxants, and inhalation anesthetics.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h.

midazolam

Midazolam, an organic compound with the chemical formula C18H13ClFN3, is used clinically to treat insomnia and can also be used to induce sleep during surgery or diagnostic tests.

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

Midazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h.

Interventions

Remimazolam Besylate

NS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h.

Intervention Type: DRUG

Propofol

Propofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h.

Intervention Type: DRUG

Midazolam

Midazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years old;
• After undergoing oral and maxillofacial surgery, it is expected that a ventilator will be needed to assist with breathing;
• mechanical ventilation patients with expected ICU stay time <72h;
• People who need immediate sedative treatment;
• Obtain informed consent from subject or legal representative;

Exclusion Criteria

• Pregnancy；
• Can not get RASS score from patients;
• Allergy to drugs;
• Proven acute and severe intracranial or spinal nerve disease due to vascular, infection, intracranial dilation, or injury;
• Uncompensated acute circulatory failure at randomization (severe hypotension with MAP<50 mmHg despite adequate fluid resuscitation and vasopressor therapy);
• Severe bradycardia (heart rate <50 beats/min) or degree II-III heart block (unless a pacemaker is installed);
• A history of long-term use of benzodiazepines or opioids;
• Subjects receiving sedation for indications other than to tolerate ventilators (e.g., epilepsy);
• Continuous sedation is unlikely to be required during mechanical ventilation (e.g. Guillain-Barre syndrome);
• Patients determined by the clinician to be unlikely to be removed from mechanical ventilation, such as diseases/injuries that primarily affect respirator neuromuscular function and conditions that clearly require long-term ventilation support (such as high spinal cord injury);
• Participation in any other interventional study (any study that assigns subjects to different treatment groups and/or performs unconventional diagnostic or monitoring procedures).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Shenzhen Hospital

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Southern medical university Nanfang hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Hongbin HU, doctor

Role: CONTACT

hobewoos@163.com

+8613922483752

Facility Contacts

Hongbin Hu, doctor

Role: primary

hobewoos@163.com

+8613922483752

Lei Huang, doctor

Role: primary

Other Identifiers

NFEC-2021-341

Identifier Type: -

Identifier Source: org_study_id