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

NCT ID: NCT05631028

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-01-01

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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Conditions

Lung Cancer; Anesthesia Induction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Remimazolam tosilate

Intervention Type: 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.

Group B

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Remimazolam tosilate

Intervention Type: 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.

Group C

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: 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.

Remimazolam tosilate

Intervention Type: 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.

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

Remimazolam tosilate

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.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China); Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyou Wei

OTHER

Sponsor Role: lead

Responsible Party

Shiyou Wei

Medical Master, Attending Doctor.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shiyou Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Tongji University

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37996787 (View on PubMed)

Other Identifiers

2022LY0416

Identifier Type: -

Identifier Source: org_study_id