Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and reduce perioperative complications. The investigators would explore the sedative effects of dexmedetomidine (DEX) with the administration of oral, intravenous and nasal drops, and detect DEX blood concentration in 15 participants, respectively. Pharmacokinetic parameters are detected at 8 time points ( before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer. The aim of this study is to investigate appropriate administration time and route for DEX sedation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral administration | Experimental | oral administration of dexmedetomidine 4μg/kg |
|
| intravenous administration | Active Comparator | intravenous administration of dexmedetomidine 0.8μg/kg |
|
| nasal administration | Experimental | nasal administration of dexmedetomidine 1μg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | oral, intravenous and nasal administration of Dexmedetomidine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dexmedetomidine pharmacokinetic curve | Dexmedetomidine (DEX) blood concentration are detected at 8 time points (before DEX administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration) in the groups of oral, intravenous and nasal drops administration of DEX. 3 ml arterial blood was collected at each time point. The blood samples are detected by mass spectrometer to detect blood concentration of DEX. Then DEX pharmacokinetic curve is made according to the DEX blood concentration. | 120 min DEX pharmacokinetics |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of sedation | Evaluated with Ramsay sedation scale Score Response
| 10min after administration |
| Evaluation of surgical field |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye, Ear, Nose and Throat Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35211010 | Derived | Wu J, Han Y, Lu Y, Zhuang Y, Li W, Jia J. Perioperative Low Dose Dexmedetomidine and Its Effect on the Visibility of the Surgical Field for Middle Ear Microsurgery: A Randomised Controlled Trial. Front Pharmacol. 2022 Feb 8;13:760916. doi: 10.3389/fphar.2022.760916. eCollection 2022. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Surgical field was evaluated according to the report Boezaart A.P.,van der Merwe J.,Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth,1995,42(5 Pt 1): 373-376. 0 No bleeding.
|
| 30min after administration |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |