Skip to main content
OpenTrials
Completed

NCT Number: NCT05631028

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Anesthesia Induction Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200082, China

About this study

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.

For more detailed measures, please follow us below.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China)

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.

Other names: Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China)

Primary outcomes

  1. ED50 and ED95 of remimazolam

    Time frame: Through study completion, an average of 3 month.

    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.

Secondary outcomes

  1. Cardiovascular response within 3 min of intubation

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

    The criteria of positive cardiovascular response to double-lumen bronchial intubation are the amplitude of mean arterial blood pressure (MAP) or heart rate (HR) fluctuations was 15% greater than the base value within 3 min after intubation . Or the patient had a tachycardia (heart rate ≥ 120 per min) or blood pressure increased more than 180 mmHg.

  2. Blood Pressure

    Time frame: 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)

    Blood pressure (systolic, diastolic, mean arterial pressure) were used to evaluate cardiovascular response. The measurements were made by Philips Patient Monitor (IntelliVue MX800).

  3. Heart Rate

    Time frame: 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(HR) were used to evaluate cardiovascular response, which was measured by Philips Patient Monitor (IntelliVue MX800).

  4. Success rate of sedation

    Time frame: Through study completion, an average of 3 month.

    Whether sedation failure occurs during the exploration of an effective dose, As assessed by modified observer's assessment of alert /sedation scale (MOAA / S), when MOAA / S ≤2 indicates loss of consciousness, implying successful sedation. The success rate of sedation for each group will be calculated only after study completion.

  5. Incidence of Hypotension

    Time frame: Through study completion, an average of 3 month.

    Systolic blood pressure < 90 mmhg or mean arterial pressure(MAP) < 60mmhg throughout the induction of anesthesia. At the entire anesthesia induction process , we measured blood pressure by patient monitor to compare whether hypotension occurred, but the incidence of hypotension will be calculated only after study completion.

  6. The incidence of reduced heart rate

    Time frame: Through study completion, an average of 3 month.

    Heart rate < 50 per min throughout the induction of anesthesia. At the entire anesthesia induction process , we measured heart rate by patient monitor to compare whether reduced heart rate occurred, but the incidence of reduced heart rate will be calculated only after study completion.

Sponsors and collaborators

Lead sponsor

Shiyou Wei

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.