Delirium Clinical Trial
Official title:
Determination of ED50 and ED95 of Single Bolus Dexmedetomidine in General Anesthesia Patients to Produce Acceptable Hemodynamic Outcomes
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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | April 23, 2020 |
Est. primary completion date | March 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. volunteer to participate in the study and sign the informed consent; 2. selective operation of thyroid gland whose anesthesia time is less than 2 hours ; 3. aged 18-55 years; 4. ASA I - II; 5. BMI 18~28kg/m2. Exclusion Criteria: 1. Mallampati grade ? or ?; 2. opening degree < 2.5 cm; 3. taking analgesic or sedative drugs for a long time before operation; 4. a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on; 5. allergic to dexmedetomidine, similar active ingredients or excipients; 6. G-6-PD deficiency; 7. a history of use of alpha 2 receptor agonists or antagonists. |
Country | Name | City | State |
---|---|---|---|
China | The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital of Wenzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate(HR) | HR changes per minutes in 10 minutes after single injection of DEX | 10min | |
Secondary | Duration of operation | Duration of operation | intraoperative, from the beginning of the cut to the end of the seam | |
Secondary | Anaesthesia time | Anaesthesia time | intraoperative, from initiation of anesthesia induction to cessation of anesthetic use | |
Secondary | Recovery time of anesthesia | Recovery time of anesthesia | within 24 hours | |
Secondary | Mean arterial pressure(MAP) | MAP changes per minutes in 10 minutes after single injection of DEX | 10min |
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