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Dexmedetomidine(DEX)is a potent and highly selective α 2 adrenergic receptor agonist. It has the pharmacological effects of sedation, hypnosis, analgesia, anti-sympathetic and neuroprotective. Its sedative effect is similar to normal sleep, and easy to wake up. DEX is widely used clinically because of its advantages and acceptable side effects. The best clinical use of DEX is uncertain, including intravenous, intramuscular, oral, intralnasal and sublingual administration. Its clinical recommended use is intravenous load infusion for more than 10 minutes, followed by continuous infusion. However, the clinical recommended usage is inconvenient, time-consuming and other shortcomings, for the growing popularity of daytime surgery, will inevitably affect the operation process and turnover. If a suitable dose range of DEX can be found for a single intravenous injection to achieve clinical efficacy quickly without significant hemodynamic effects, this will improve the patient's postoperative recovery. We will speed up the utilization and turnover of medical resources. The aim of this study was to investigate the optimal dosage of DEX for single intravenous injection.
Patients undergoing thyroidectomy under general anesthesia were treated with routine anesthesia induction and maintenance, and DEX was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of DEX was 0.1 ug/kg. If the cardiovascular reaction was positive (MAP or heart rate was more than 20% before intravenous injection), the dosage of DEX in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of DEX by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew. There were 8 turning points of cardiovascular reaction and the test was completed. The changes of blood pressure and heart rate per minute in 10min were recorded after single bolus. The dosimetric map of patients with DEX was drawn, and the ED50 and ED95 were calculated by probit probabilistic unit regression (Bills method).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine dexmedetomidine, 0.1ug/kg up or down Other Name: precedex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of dexmedetomidine was 0.1 ug/kg. If the cardiovascular reaction was positive (mean arterial pressure or heart rate was more than 20% before intravenous injection), the dosage of Dexmedetomidine in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of dexmedetomidine by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate(HR) | HR changes per minutes in 10 minutes after single injection of DEX | 10min |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of operation | Duration of operation | intraoperative, from the beginning of the cut to the end of the seam |
| Anaesthesia time | Anaesthesia time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huacheng Liu | Contact | 18957755138 | huachengliu@163.com | |
| Chengyu Wang | Contact | 15158719196 | 2322313983@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Li | Second Affiliated Hospital of Wenzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325027 | China |
De-identified individual participant data for all primary and secondary outcome measures will be available.
Data will be available within 6 months of study complettion.
Data access request will be reviewed by an external independent review panel.Requestors will be required to sign a Data access agreement.
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| intraoperative, from initiation of anesthesia induction to cessation of anesthetic use |
| Recovery time of anesthesia | Recovery time of anesthesia | within 24 hours |
| Mean arterial pressure(MAP) | MAP changes per minutes in 10 minutes after single injection of DEX | 10min |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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