Lung CancerNCT05631028
95% Effective Dose(ED95) of Remimazolam During Dexmedetomidine Pretreatment
A study testing Dexmedetomidine and Remimazolam tosilate in people with Lung Cancer and Anesthesia Induction, run by Shiyou Wei at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Anesthesia Induction
- What is being tested?
- Dexmedetomidine and Remimazolam tosilate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Optional Video-Assisted Thoracoscopic Surgery (VATS)
- More than 18 years old
- American Association of Anesthesiologists (ASA) grade I~III
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
For more detailed measures, please follow us below.
- Conditions
- Lung Cancer, Anesthesia Induction
- Being tested
- Dexmedetomidine, Remimazolam tosilate
- Keywords
- Anaesthetic, Remimazolam, Cardiovascular Reaction
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China)
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 tosilateDrug
Also called Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine; Drug: Remimazolam tosilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 month.
Secondary outcomes (6)
Cardiovascular response within 3 min of intubation
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.
Measured: The evaluation time included the start of endotracheal intubation until three minutes after completion.
Blood Pressure
Blood pressure (systolic, diastolic, mean arterial pressure) were used to evaluate cardiovascular response. The measurements were made by Philips Patient Monitor (IntelliVue MX800).
Measured: 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
Heart rate(HR) were used to evaluate cardiovascular response, which was measured by Philips Patient Monitor (IntelliVue MX800).
Measured: 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
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.
Measured: Through study completion, an average of 3 month.
Incidence of Hypotension
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.
Measured: Through study completion, an average of 3 month.
The incidence of reduced heart rate
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.
Measured: Through study completion, an average of 3 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Dec 2022
- Primary completion30 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Shiyou Wei, MD, Principal investigator, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631028
- Sponsor's protocol ID
- 2022LY0416
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37996787
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05631028
- Acronym / sponsor ID
- 2022LY0416
- Conditions
- Lung Cancer, Anesthesia Induction
- Keywords
- Anaesthetic, Remimazolam, Cardiovascular Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
For more detailed measures, please follow us below.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Remimazolam tosilateDexmedetomidine 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 B | Experimental | Drug: Dexmedetomidine, Drug: Remimazolam tosilateDexmedetomidine 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 C | Experimental | Drug: Dexmedetomidine, Drug: Remimazolam tosilateDexmedetomidine 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Optional Video-Assisted Thoracoscopic Surgery (VATS)
- More than 18 years old
- American Association of Anesthesiologists (ASA) grade I~III
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China)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. | Drug | Group B, Group C |
| Remimazolam tosilateAlso: Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China)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. | Drug | Group A, Group B, Group C |
Primary outcome
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.
6 secondary outcomes
Cardiovascular response within 3 min of intubation
Time frame: The evaluation time included the start of endotracheal intubation until three minutes after completion.
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)
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)
Success rate of sedation
Time frame: Through study completion, an average of 3 month.
Incidence of Hypotension
Time frame: Through study completion, an average of 3 month.
The incidence of reduced heart rate
Time frame: Through study completion, an average of 3 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 37996787Wei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyou Wei, MD principal investigator
Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Remimazolam tosilate in people with Lung Cancer and Anesthesia Induction, run by Shiyou Wei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED50 and ED95 of remimazolam (time frame: Through study completion, an average of 3 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.