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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride 0.1 MG/ML | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15min after giving the drug, every five minutes during anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Feng, MD,PhD | Contact | 86-010-88325581 | yifeng65@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Feng, MD,PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19713256 | Background | 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. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 0.9% Sodium Chloride Injection | Drug | 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. |
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| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |