Clinical trial NCT05631028: 95% Effective Dose(ED95) of Remimazolam During Dexmedetomidine Pretreatment
Official title: Effect of Dexmedetomidine Pretreatment on The Effective Dose of Remimazolam Tosilate Inhibiting Cardiovascular Response to Intubation of Double-Lumen Endobronchial Tubes: A Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Anesthesia Induction
Keywords: Anaesthetic
Remimazolam
Cardiovascular Reaction
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

Brief 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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Eligibility criteria: Inclusion Criteria:

* Optional Video-Assisted Thoracoscopic Surgery (VATS)
* More than 18 years old
* American Association of Anesthesiologists (ASA) grade I\~III

Exclusion Criteria:

* Systolic pressure ≥160 mmHg or diastolic pressure ≥110 mmHg or heart rate ≥ 110 beats / min in the operating room when quietly
* Long-term use of analgesia or sedation drugs before surgery
* Pregnancy, lactation, pregnancy possibility and planned pregnancy
* Allergy history of the test drug
* Mental illness or an inability to communicate normally.

Primary outcomes:
measure: ED50 and ED95 of remimazolam
timeFrame: Through study completion, an average of 3 month.
Secondary outcomes:
measure: Cardiovascular response within 3 min of intubation
timeFrame: The evaluation time included the start of endotracheal intubation until three minutes after completion.
measure: Blood Pressure
timeFrame: Intraoperative (Four time points. Time 1: When calm in the operating room. Time 2: At the end of dexmedetomidine pumping. Time 3: End of the remimazolam infusion. Time 4:the start of endotracheal intubation until 3 min after completion)
measure: Heart Rate
timeFrame: Intraoperative (Four time points. Time 1: When calm in the operating room. Time 2: At the end of dexmedetomidine pumping. Time 3: End of the remimazolam infusion. Time 4:the start of endotracheal intubation until 3 min after completion)
measure: Success rate of sedation
timeFrame: Through study completion, an average of 3 month.
measure: Incidence of Hypotension
timeFrame: Through study completion, an average of 3 month.
measure: The incidence of reduced heart rate
timeFrame: Through study completion, an average of 3 month.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Tongji University
name: Shiyou Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: