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

NCT05606315 | Unknown Phase 4

• 1 other identifier: NFEC-2021-341
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 2

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.

Conditions

Remimazolam Besylate; Sedation; ICU

Keywords

Remimazolam besylate; Oral cancer; Sedation; ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to recovery

  From date of using the intervention drugs until the date of recovery, up to 28 days.

• Drug onset time

  From date of using the intervention drugs until the date of recovery, up to 28 days.

• Time to reach the required sedation score

  From date of using the intervention drugs until the date of recovery, up to 28 days.

• Mechanical ventilation time during ICU

  From the time you enter ICU to the time you leave ICU.

• Length of ICU stay and total hospital stay

  From hospitalization to discharge.

Study Arms (3)

Remimazolam besylate

EXPERIMENTAL

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.

Drug: Remimazolam Besylate

propofol

ACTIVE COMPARATOR

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.

Drug: Propofol

midazolam

ACTIVE COMPARATOR

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.

Drug: Midazolam

Interventions

Remimazolam Besylate DRUG

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

Remimazolam besylate

Propofol DRUG

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

propofol

Midazolam DRUG

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

midazolam

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Peking University Shenzhen Hospital: collaborator

Study Sites (2)

Southern medical university Nanfang hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

NOT YET RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hongbin HU, doctor

CONTACT

+8613922483752; hobewoos@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 4, 2022
• Study Start: March 16, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

CN (2)