Sedation ComplicationNCT04652427
Application of Dexmedetomidine Hydrochloride Injection in Anesthesia for Patients Without Tracheal Intubation
A study testing Dexmedetomidine Hydrochloride 0.1 MG/ML and 0.9% Sodium Chloride Injection in people with Sedation Complication, run by Peking University People's Hospital at 1 site in China.
Trial summary
With 0.9% sodium chloride injection as a placebo control, to evaluate the effectiveness and safety of dexmedetomidine hydrochloride injection for sedation in patients with non-tracheal intubation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sedation Complication
- What is being tested?
- Dexmedetomidine Hydrochloride 0.1 MG/ML and 0.9% Sodium Chloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to Aug 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) 18~65 years old (including 18 and 65 years old), no gender limit;
- 2) 18 kg/m2 ≤BMI≤30 kg/m2;
- 3) For patients undergoing elective surgery under non-general anesthesia, the expected duration of surgery is ≥30min;
- 4) ASA classification is Ⅰ～Ⅲ;
- 5) After the patient has a full understanding of the purpose and significance of this trial, he/she voluntarily participates in this clinical trial, agrees to contraception during the study period and within 3 days after the study medication, and signs an informed consent Intent.
Who cannot join
- 1) Patients who have received anesthesia or surgery within 7 days before randomization;
- 2) Patients with a history of acute myocardial infarction or unstable angina within 6 months before the screening period;
- 3) Bradycardia (heart rate <50 beats/min), Ⅱ or Ⅲ degree atrioventricular block (not including Patients with pacemakers) and other severe arrhythmia and heart failure;
- 4) Hypertension patients who are not satisfactorily controlled (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg), or patients with hypotension (systolic blood pressure <90 mmHg);
- 5) People with mental system diseases (such as schizophrenia, depression, etc.) or cognitive impairment; Those with a history of epilepsy;
- 6) Those who suffer from bronchial asthma or other severe respiratory diseases;
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- 7) Abnormal blood coagulation function (PT prolongation exceeds the upper limit of normal for 3 seconds and/or APTT prolongation exceeds. The upper limit of the normal value is 10 seconds);
- 8) Abnormal liver and kidney function (ALT and/or AST>2 times the upper limit of normal, total bilirubin>1.5 Times the upper limit of normal, blood creatinine>1.5 times the upper limit of normal);
- 9) Those who have used α2 adrenergic receptor agonists or antagonists within 14 days before randomization;
- 10) Those who have used sedatives such as benzodiazepines and barbiturates within 7 days before randomization;
- 11) People with a history of drug abuse, drug abuse and alcohol abuse, among which alcohol abuse is defined as the average daily drinking Liquor exceeds 2 units of alcohol (1 unit = 360 ml of beer or 45 ml of alcohol is 40% white wine or 150 ml wine);
- 12) Those who are allergic to dexmedetomidine, midazolam, fentanyl and other pharmaceutical ingredients or components;
- 13) Women who are pregnant or breastfeeding;
- 14) Those who have participated in other clinical trials within 3 months before randomization;
- 15) The researcher believes that there are any other circumstances that are not suitable for selection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yi Feng, MD,PhD, 86-010-88325581, yifeng65@sina.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial Program on the Effectiveness and Safety of Dexmedetomidine Hydrochloride Injection for Sedation in Patients Without Tracheal Intubation
With 0.9% sodium chloride injection as a placebo control, to evaluate the effectiveness and safety of dexmedetomidine hydrochloride injection for sedation in patients with non-tracheal intubation
Read the detailed description
Clinically common non-systemic anesthesia mainly includes surface anesthesia, local immersion anesthesia, nerve block, regional blocking, intravertebral anesthesia. Patients under non-general anesthesia surgery, is still in a more sober state, easily due to external factors and increase the psychological and mental burden, even if the ideal anaesthetic effect can be achieved, but for autonomic nerve activities can not be completely and effectively eliminated. Hydrochloric acid right-metomidine is an alpha2-adrenaline receptor agonisant developed by Orion Pharma (Finland) and Abott (Usa) in collaboration. Unlike other sedative hypnotic sedatives, hydrochloric acid right metamine produces a sedative hypnotic effect by acting on the blue spot nuclear alpha2 receptor and the inflammatory endogenous sleep-stimulating pathway, allowing the patient to maintain a natural sleep state of non-fast eye III, which is characterized by the patient being stimulated or speech-altered, and does not produce respiratory inhibition during sedative hypnosis. In addition to the sedative effect, the right metomisurein also has anti-anxiety, reduce stress response, stable hemodynamics, analgesic, inhibitsalival secretion, anti-cold and diuretic function, and other sedative analgesic drugs when used with good synergy, can significantly reduce the use of other sedative analgesic drugs.
- Conditions
- Sedation Complication
- Being tested
- Dexmedetomidine Hydrochloride 0.1 MG/ML, 0.9% Sodium Chloride Injection
- Keywords
- effectiveness, security, Dexmedetomidine Hydrochloride, Non-tracheal intubation anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Hydrochloride 0.1 MG/MLDrug
Also called sedation
At least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration.
0.9% Sodium Chloride InjectionDrug
Also called saline solution
At least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration.
| Study group | Role | What they receive |
|---|---|---|
| Use Dexmedetomidine Hydrochloride to maintain a sedative | Experimental | Slow static injection at a load-loaded dose of 1.0/g/kg (half of the load dose in ophthalmology surgery), infusion time of 10 to 15 min, followed by the maintenance phase, maintenance dose set at an initial 0.6/g/kg/h, maintenance during administration The researchers, using the results of the OAA/S assessment, made a comprehensive judgment to adjust the infusion rate in the range of 0.2 to 1.0/g/kg/h to obtain the desired sedative effect, and anaesthetic can be performed when the study drug was given a duration of 15 minutes and the required sedative level was reached. Maintain the administration until the end of the operation. Receives: Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML |
| Sedative were maintained with a 0.9% sodium chloride injection | Placebo comparator | Slow static injection at a load-loaded dose of 1.0/g/kg (half of the load dose in ophthalmology surgery), infusion time of 10 to 15 min, followed by the maintenance phase, maintenance dose set at an initial 0.6/g/kg/h, maintenance during administration The researchers, using the results of the OAA/S assessment, made a comprehensive judgment to adjust the infusion rate in the range of 0.2 to 1.0/g/kg/h to obtain the desired sedative effect, and anaesthetic can be performed when the study drug was given a duration of 15 minutes and the required sedative level was reached. Maintain the administration until the end of the operation. Receives: Drug: 0.9% Sodium Chloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the OAA/S score of the subject during the study medication.
At least 15 minutes before anesthesia, the study drug was given sedation according to the dosing schedule. At the end of the loading dose of the study drug, an alertness/sedation score (OAA/S) was performed, and then it entered the maintenance dosing phase, which was performed every 5 minutes until the end of the operation OAA/S score. OAA/S≤4 means that the required level of sedation has been reached, and anesthesia can be performed after starting the study drug for ≥15 minutes and reaching the required level of sedation. During the administration of the study drug, OAA/S ≤4 should always be maintained.
Measured: 15min after giving the drug, every five minutes during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start20 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
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 Sedation ComplicationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD,PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652427
- Sponsor's protocol ID
- 2020PHC003
- Status last verified
- Dec 2020
- First submitted
- 20 Aug 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
PubMed 19713256
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial Program on the Effectiveness and Safety of Dexmedetomidine Hydrochloride Injection for Sedation in Patients Without Tracheal Intubation
- ClinicalTrials.gov ID
- NCT04652427
- Acronym / sponsor ID
- 2020PHC003
- Conditions
- Sedation Complication
- Keywords
- effectiveness, security, Dexmedetomidine Hydrochloride, Non-tracheal intubation anesthetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 3 Dec 2020 (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.
With 0.9% sodium chloride injection as a placebo control, to evaluate the effectiveness and safety of dexmedetomidine hydrochloride injection for sedation in patients with non-tracheal intubation
Detailed description
Clinically common non-systemic anesthesia mainly includes surface anesthesia, local immersion anesthesia, nerve block, regional blocking, intravertebral anesthesia. Patients under non-general anesthesia surgery, is still in a more sober state, easily due to external factors and increase the psychological and mental burden, even if the ideal anaesthetic effect can be achieved, but for autonomic nerve activities can not be completely and effectively eliminated. Hydrochloric acid right-metomidine is an alpha2-adrenaline receptor agonisant developed by Orion Pharma (Finland) and Abott (Usa) in collaboration. Unlike other sedative hypnotic sedatives, hydrochloric acid right metamine produces a sedative hypnotic effect by acting on the blue spot nuclear alpha2 receptor and the inflammatory endogenous sleep-stimulating pathway, allowing the patient to maintain a natural sleep state of non-fast eye III, which is characterized by the patient being stimulated or speech-altered, and does not produce respiratory inhibition during sedative hypnosis. In addition to the sedative effect, the right metomisurein also has anti-anxiety, reduce stress response, stable hemodynamics, analgesic, inhibitsalival secretion, anti-cold and diuretic function, and other sedative analgesic drugs when used with good synergy, can significantly reduce the use of other sedative analgesic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use Dexmedetomidine Hydrochloride to maintain a sedative | Experimental | Drug: Dexmedetomidine Hydrochloride 0.1 MG/MLSlow static injection at a load-loaded dose of 1.0/g/kg (half of the load dose in ophthalmology surgery), infusion time of 10 to 15 min, followed by the maintenance phase, maintenance dose set at an initial 0.6/g/kg/h, maintenance during administration The researchers, using the results of the OAA/S assessment, made a comprehensive judgment to adjust the infusion rate in the range of 0.2 to 1.0/g/kg/h to obtain the desired sedative effect, and anaesthetic can be performed when the study drug was given a duration of 15 minutes and the required sedative level was reached. Maintain the administration until the end of the operation. |
| Sedative were maintained with a 0.9% sodium chloride injection | Placebo comparator | Drug: 0.9% Sodium Chloride InjectionSlow static injection at a load-loaded dose of 1.0/g/kg (half of the load dose in ophthalmology surgery), infusion time of 10 to 15 min, followed by the maintenance phase, maintenance dose set at an initial 0.6/g/kg/h, maintenance during administration The researchers, using the results of the OAA/S assessment, made a comprehensive judgment to adjust the infusion rate in the range of 0.2 to 1.0/g/kg/h to obtain the desired sedative effect, and anaesthetic can be performed when the study drug was given a duration of 15 minutes and the required sedative level was reached. Maintain the administration until the end of the operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) 18~65 years old (including 18 and 65 years old), no gender limit;
- 2) 18 kg/m2 ≤BMI≤30 kg/m2;
- 3) For patients undergoing elective surgery under non-general anesthesia, the expected duration of surgery is ≥30min;
- 4) ASA classification is Ⅰ～Ⅲ;
- 5) After the patient has a full understanding of the purpose and significance of this trial, he/she voluntarily participates in this clinical trial, agrees to contraception during the study period and within 3 days after the study medication, and signs an informed consent Intent.
Key exclusion criteria (15 listed)
- 1) Patients who have received anesthesia or surgery within 7 days before randomization;
- 2) Patients with a history of acute myocardial infarction or unstable angina within 6 months before the screening period;
- 3) Bradycardia (heart rate <50 beats/min), Ⅱ or Ⅲ degree atrioventricular block (not including Patients with pacemakers) and other severe arrhythmia and heart failure;
- 4) Hypertension patients who are not satisfactorily controlled (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg), or patients with hypotension (systolic blood pressure <90 mmHg);
- 5) People with mental system diseases (such as schizophrenia, depression, etc.) or cognitive impairment; Those with a history of epilepsy;
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 |
|---|---|---|
| Dexmedetomidine Hydrochloride 0.1 MG/MLAlso: sedationAt least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration. | Drug | Use Dexmedetomidine Hydrochloride to maintain a sedative |
| 0.9% Sodium Chloride InjectionAlso: saline solutionAt least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration. | Drug | Sedative were maintained with a 0.9% sodium chloride injection |
Primary outcome
Changes in the OAA/S score of the subject during the study medication.
Time frame: 15min after giving the drug, every five minutes during anesthesia
At least 15 minutes before anesthesia, the study drug was given sedation according to the dosing schedule. At the end of the loading dose of the study drug, an alertness/sedation score (OAA/S) was performed, and then it entered the maintenance dosing phase, which was performed every 5 minutes until the end of the operation OAA/S score. OAA/S≤4 means that the required level of sedation has been reached, and anesthesia can be performed after starting the study drug for ≥15 minutes and reaching the required level of sedation. During the administration of the study drug, OAA/S ≤4 should always be maintained.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 19713256Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.
- 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.
Yi Feng, MD,PhD principal investigator
Peking University People's Hospital
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 Hydrochloride 0.1 MG/ML and 0.9% Sodium Chloride Injection in people with Sedation Complication, run by Peking University People's Hospital 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Feng, MD,PhD (86-010-88325581, yifeng65@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the OAA/S score of the subject during the study medication. (time frame: 15min after giving the drug, every five minutes during anesthesia). 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 NCT04652427, 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 3 Dec 2020.