Back to resultsA Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
Primary Purpose
Anxiety, Preoperative Care, Pharmacokinetics
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring Dexmedetomidine
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.
Sites / Locations
- Eye, Ear, Nose and Throat Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
oral administration
intravenous administration
nasal administration
Arm Description
oral administration of dexmedetomidine 4μg/kg
intravenous administration of dexmedetomidine 0.8μg/kg
nasal administration of dexmedetomidine 1μg/kg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT03800641
First Posted
January 7, 2019
Last Updated
January 7, 2022
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03800641
Brief Title
A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
Official Title
A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2019 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
January 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Preoperative Care, Pharmacokinetics, Emergence Delirium
Keywords
Dexmedetomidine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral administration
Arm Type
Experimental
Arm Description
oral administration of dexmedetomidine 4μg/kg
Arm Title
intravenous administration
Arm Type
Active Comparator
Arm Description
intravenous administration of dexmedetomidine 0.8μg/kg
Arm Title
nasal administration
Arm Type
Experimental
Arm Description
nasal administration of dexmedetomidine 1μg/kg
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
oral, intravenous and nasal administration of Dexmedetomidine
Primary Outcome Measure Information:
Title
Dexmedetomidine pharmacokinetic curve
Description
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.
Time Frame
120 min DEX pharmacokinetics
Secondary Outcome Measure Information:
Title
Effect of sedation
Description
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
Time Frame
10min after administration
Title
Evaluation of surgical field
Description
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.
Time Frame
30min after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Eye, Ear, Nose and Throat Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35211010
Citation
Wu J, Han Y, Lu Y, Zhuang Y, Li W, Jia J. Perioperative Low Dose Dexmedetomidine and Its Effect on the Visibility of the Surgical Field for Middle Ear Microsurgery: A Randomised Controlled Trial. Front Pharmacol. 2022 Feb 8;13:760916. doi: 10.3389/fphar.2022.760916. eCollection 2022.
Results Reference
derived
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A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
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