A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

Study Overview
=================
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.

Official Title
-----------------
A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops

Conditions
-----------------
Anxiety, Preoperative Care, Pharmacokinetics, Emergence Delirium

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral administration<br>oral administration of dexmedetomidine 4μg/kg | Drug: Dexmedetomidine<br>* oral, intravenous and nasal administration of Dexmedetomidine<br>|
| Active Comparator: intravenous administration<br>intravenous administration of dexmedetomidine 0.8μg/kg | Drug: Dexmedetomidine<br>* oral, intravenous and nasal administration of Dexmedetomidine<br>|
| Experimental: nasal administration<br>nasal administration of dexmedetomidine 1μg/kg | Drug: Dexmedetomidine<br>* oral, intravenous and nasal administration of Dexmedetomidine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine