A Phase 4 interventional study of Dexmedetomidine in Delirium, Postoperative Complications and Pathologic Processes, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Phase 4, Interventional, and Prevention
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).
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 42 is below the median of 119 across 689 interventional studies indexed under Postoperative Complications.
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Drug: Dexmedetomidine dexmedetomidine, 0.1ug/kg up or down Other Name: precedex
Drug: Dexmedetomidine
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.
Also known as: see arms
Heart rate(HR)
HR changes per minutes in 10 minutes after single injection of DEX
Time frame: 10min
Duration of operation
Duration of operation
Time frame: intraoperative, from the beginning of the cut to the end of the seam
Anaesthesia time
Anaesthesia time
Time frame: intraoperative, from initiation of anesthesia induction to cessation of anesthetic use
Recovery time of anesthesia
Recovery time of anesthesia
Time frame: within 24 hours
Mean arterial pressure(MAP)
MAP changes per minutes in 10 minutes after single injection of DEX
Time frame: 10min
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be available.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Wenzhou Medical University