NCT03800641

A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety
• Preoperative Care
• Pharmacokinetics
• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	oral, intravenous and nasal administration of Dexmedetomidine

Timeline

• Start date: 2019-01-11
• Primary completion: 2019-03-29
• Completion: 2020-01-23
• First posted: 2019-01-11
• Last updated: 2022-01-11

Locations

1 site across 1 country: China