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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05606315
Other study ID # NFEC-2021-341
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 16, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Nanfang Hospital, Southern Medical University
Contact Hongbin HU, doctor
Phone +8613922483752
Email hobewoos@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 285
Est. completion date December 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remimazolam Besylate
NS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h.
Propofol
Propofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h.
Midazolam
Midazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h.

Locations

Country Name City State
China Southern medical university Nanfang hospital Guangzhou Guangdong
China Peking University Shenzhen Hospital Shenzhen Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Extubation time The time from discontinuation of sedation to withdrawal of tracheal catheter. From date of using the intervention drugs until the date of extubation, up to 28 days.
Secondary Time to recovery The time from withdrawal of sedation to recovery. From date of using the intervention drugs until the date of recovery, up to 28 days.
Secondary Drug onset time The time from discontinuation of sedation to meeting the sedation score requirements (RASS score < -3). From date of using the intervention drugs until the date of recovery, up to 28 days.
Secondary Time to reach the required sedation score The proportion of time spent meeting sedation requirements (RASS score <-3) to total time spent on medication From date of using the intervention drugs until the date of recovery, up to 28 days.
Secondary Mechanical ventilation time during ICU Time from insertion to withdrawal of tracheal catheter. From the time you enter ICU to the time you leave ICU.
Secondary Length of ICU stay and total hospital stay Time from admission to ICU to leave ICU;The time from admission to discharge. From hospitalization to discharge.
Secondary Adverse event rate The proportion of cases with adverse events to the total number of cases for evaluation of adverse events. From date of using the intervention drugs until the date of leaving hospital.
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