A Phase 4 interventional study of Remimazolam Besylate and Propofol in Sedation, ICU and Remimazolam Besylate, sponsored by Nanfang Hospital, Southern Medical University. Terminated at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 4, Interventional, and Treatment
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.
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.
Therefore, we conducted a multicenter, randomized, non-inferiority pilot study to compare the efficacy and safety of remimazolam besylate, propofol, and midazolam in this patient population.
377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.
This study's enrollment of 117 is above the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.
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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, 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, 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
NS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h.
Propofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h.
Midazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h.
Extubation time
The time from discontinuation of sedation to withdrawal of tracheal catheter.
Time frame: From date of using the intervention drugs until the date of extubation, up to 28 days.
Time to recovery
The time from withdrawal of sedation to recovery.
Time frame: From date of using the intervention drugs until the date of recovery, up to 28 days.
Drug onset time
The time from discontinuation of sedation to meeting the sedation score requirements (RASS score \< -3).
Time frame: From date of using the intervention drugs until the date of recovery, up to 28 days.
Time to reach the required sedation score
The proportion of time spent meeting sedation requirements (RASS score \<-3) to total time spent on medication
Time frame: From date of using the intervention drugs until the date of recovery, up to 28 days.
Mechanical ventilation time during ICU
Time from insertion to withdrawal of tracheal catheter.
Time frame: From the time you enter ICU to the time you leave ICU.
Length of ICU stay and total hospital stay
Time from admission to ICU to leave ICU;The time from admission to discharge.
Time frame: From hospitalization to discharge.
Adverse event rate
The proportion of cases with adverse events to the total number of cases for evaluation of adverse events.
Time frame: From date of using the intervention drugs until the date of leaving hospital.
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University