95% Effective Dose(ED95) of Remimazolam During Dexmedetomidine Pretreatment
Condition: Lung Cancer; Anesthesia Induction
Study type: Interventional

Summary: 
      General anesthesia with double-lumen endobronchial tubes intubation is the main anesthesia
      method in thoracic surgery.However, double-lumen endobronchial tubes intubation can produce
      greater stimulation and cause more cardiovascular reactions, and the ideal anesthetic drugs
      can effectively reduce adverse reactions.Remimazolam is a new type of benzodiazepine drug
      that can be safely used for the induction and maintenance of general anesthesia, and it is an
      ideal and short-acting anesthetic alternative.As the new drug has had a short clinical entry
      time.There are few clinical data in all aspects, so it is necessary to clarify its rational
      use in the induction of anesthesia.Dexmedetomidine is a highly selective α 2 adrenergic
      receptor agonist, and it is currently the most popular adjunct to clinical
      anesthesia.However, the clinical data of anesthesia induction by dexmedetomidine combined
      with Remimazolam are rarely reported.

      In the case of prior use of dexmedetomidine, to explore 50% effective dose (ED50) and ED95 of
      Remimazolam for the induction of anesthesia to inhibit the cardiovascular response of
      double-lumen bronchial intubation, in order to provide more data for the rational use of
      remimazolam and a reference for clinical rational drug use.
    

Detailed description: 
      This study is a clinical trial of adaptive design dose exploration evaluating the effect of
      dexmedetomidine pretreatment on the effective dose of remimazolam tosilate inhibiting
      cardiovascular response to intubation of double-lumen endobronchial tubes.Following the
      design principle, conduct dynamic exploration by sequential method, using the near ED95 drug
      dose for subjects according to the pretest.To determine whether the next subject increases or
      decreases the pre-set fixed drug dose according to the previous subject. The trial was
      stopped when seven exchange points occurred, at which point the total sample size was
      obtained.

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Intervention name(s): Dexmedetomidine; Remimazolam tosilate
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine is the most popular adjuvant to anesthesia. Groups was grouped according to different preadministered doses of dexmedetomidine. This allows a more comprehensive assessment of remimazolam under different use. Three groups were set separately, and Group A, Group B, and Group C correspond to 0,0.5, and 1 μg/kg at first 10 mins , respectively.; Remimazolam tosilate has a short clinical time and a lack of combination with dexmedetomidine for dual-lumen endotracheal intubation. The optimal use dose of Remimazolam tosilate was explored separately from different dexmedetomidine doses.
Other intervention name(s): Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China); Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China)
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This study is a clinical trial of dynamic design dose exploration evaluating the effect of dexmedetomidine pretreatment on the effective dose of remimazolam tosilate inhibiting cardiovascular response to intubation of double-lumen endobronchial tubes. Following the design principle, conduct dynamic exploration by sequential method, using the near ED95 drug dose for subjects according to the pretest.To determine whether the next subject increases or decreases the pre-set fixed drug dose according to the previous subject. The trial was stopped when seven exchange points occurred, at which point the total sample size was obtained.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anaesthetic; Remimazolam; Cardiovascular Reaction