A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: oral administration oral administration of dexmedetomidine 4μg/kg |
Drug: Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine
|
| Active Comparator: intravenous administration intravenous administration of dexmedetomidine 0.8μg/kg |
Drug: Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine
|
| Experimental: nasal administration nasal administration of dexmedetomidine 1μg/kg |
Drug: Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine
|
Outcome Measures
Primary Outcome Measures
- Dexmedetomidine pharmacokinetic curve [120 min DEX pharmacokinetics]
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.
Secondary Outcome Measures
- Effect of sedation [10min after administration]
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
- Evaluation of surgical field [30min after administration]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye, Ear, Nose and Throat Hospital | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EyeEntFudan