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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800641
Other study ID # EyeEntFudan
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 11, 2019
Est. completion date January 23, 2020

Study information

Verified date January 2022
Source Eye & ENT Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine

Locations

Country Name City State
China Eye, Ear, Nose and Throat Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

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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