Anxiety Clinical Trial
Official title:
A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops
Verified date | January 2022 |
Source | Eye & ENT Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | January 23, 2020 |
Est. primary completion date | March 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 45 participants who undergo tympanoplasty would be enrolled after signment the informed consent. Exclusion Criteria: - The participants were excluded with any diseases about respiration, circulation, liver and kidney. |
Country | Name | City | State |
---|---|---|---|
China | Eye, Ear, Nose and Throat Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Eye & ENT Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Effect of sedation | Evaluated with Ramsay sedation scale Score Response
Anxious or restless or both Cooperative, orientated and tranquil Responding to commands Brisk response to stimulus Sluggish response to stimulus No response to stimulus |
10min after administration | |
Secondary | Evaluation of surgical field | 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. Slight bleeding - no suctioning of blood required. Slight bleeding - occasional suctioning required. Surgical field not threatened. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible. |
30min after administration |
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