95% Effective Dose(ED95) of Remimazolam During Dexmedetomidine Pretreatment

NCT05631028 | Completed

• 1 other identifier: 2022LY0416
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Anesthesia Induction

Keywords

Anaesthetic; Remimazolam; Cardiovascular Reaction

Outcome Measures

Primary Outcomes (1)

• ED50 and ED95 of remimazolam

  Half of the effective doses (ED50) and 95% effective doses (ED95 ) of remimazolam to inhibit the cardiovascular response of double-lumen bronchial intubation during anesthesia induction after dexmedetomidine (DEX) pretreatment. Positive cardiovascular responses is determined when the highest hypertension or heart rate caused by bronchial intubation exceeds 15% of the baseline value. And the test will be ended with seven positive to negative transitions through sequential dose exploration. ED50 and ED 95 will be calculated by probit regression using the collected dose and cardiovascular response outcome data after study completion.

  Through study completion, an average of 3 month.

Secondary Outcomes (6)

• Cardiovascular response within 3 min of intubation

  The evaluation time included the start of endotracheal intubation until three minutes after completion.

• Blood Pressure

  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)

• Heart Rate

  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)

• Success rate of sedation

  Through study completion, an average of 3 month.

• Incidence of Hypotension

  Through study completion, an average of 3 month.

Study Arms (3)

Group A

EXPERIMENTAL

Dexmedetomidine pretreatment dose was 0. The effective dose of remimazolam tosilate inhibiting cardiovascular response during double-lumen tracheal intubation in elderly patients (age \> 65 years) and young patients (18 \< age \<65 years) was explored respectively, without the use of dexmedetomidine. The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.25 mg / kg, and the adjusted unit dose was 0.01mg.

Drug: Remimazolam tosilate

Group B

EXPERIMENTAL

Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China) was diluted to 50ml and the pretreatment dose was 0.5μg/kg at first 10 mins.The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.15 mg / kg, and the adjusted unit dose was 0.01mg.

Drug: Dexmedetomidine; Drug: Remimazolam tosilate

Group C

EXPERIMENTAL

Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China) was diluted to 50ml and the pretreatment dose was 1μg/kg at first 10 mins.The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.1 mg / kg, and the adjusted unit dose was 0.01mg.

Drug: Dexmedetomidine; Drug: Remimazolam tosilate

Interventions

Dexmedetomidine DRUG

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.

Also known as: Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China)

Group B; Group C

Remimazolam tosilate DRUG

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.

Also known as: Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China)

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyou Wei: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Related Publications (1)

• Wei S, Liu X, Chang R, Chen X, Zheng T, Wang J, Liu H, Zhang F, Song J, Lv X. Effect of pre-use of Dexmedetomidine on the effective inhibitory dose of remimazolam tosilate on positive cardiovascular response in double-lumen endobronchial intubation: a clinical study. BMC Anesthesiol. 2023 Nov 23;23(1):382. doi: 10.1186/s12871-023-02305-8.

  PMID: 37996787 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dexmedetomidine; Injections; Powders

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Shiyou Wei, MD

  Tongji University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Master, Attending Doctor.

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 30, 2022
• Study Start: December 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 1, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)