A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800641
• Other study ID #: EyeEntFudan
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Delirium
• Emergence Delirium
• Pharmacokinetics
• Preoperative Care

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