Acceptable Hemodynamic Changes in Dexmedetomidine for Single Intravenous Bolus Injection (NCT03655847) | Clinical Trial Compass
UnknownPhase 4
Acceptable Hemodynamic Changes in Dexmedetomidine for Single Intravenous Bolus Injection
China42 participantsStarted 2018-05-23
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. volunteer to participate in the study and sign the informed consent;
✓. selective operation of thyroid gland whose anesthesia time is less than 2 hours ;
✓. aged 18-55 years;
✓. ASA I - II;
✓. BMI 18\~28kg/m2.
Exclusion criteria
✕. Mallampati grade Ⅲ or Ⅳ;
✕. opening degree \< 2.5 cm;
✕. taking analgesic or sedative drugs for a long time before operation;
✕. a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on;
✕. allergic to dexmedetomidine, similar active ingredients or excipients;
✕. G-6-PD deficiency;
What they're measuring
1
Heart rate(HR)
Timeframe: 10min
Trial details
NCT IDNCT03655847
SponsorSecond Affiliated Hospital of Wenzhou Medical University