A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

Eye & ENT Hospital of Fudan University

Status and phase: Completed; Phase 4

Conditions: Preoperative Care; Emergence Delirium; Anxiety; Pharmacokinetics

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03800641

EyeEntFudan

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

oral administration

Experimental group

Description:

oral administration of dexmedetomidine 4μg/kg

Treatment:

Drug: Dexmedetomidine

intravenous administration

Active Comparator group

Description:

intravenous administration of dexmedetomidine 0.8μg/kg

Treatment:

Drug: Dexmedetomidine

nasal administration

Experimental group

Description:

nasal administration of dexmedetomidine 1μg/kg

Treatment:

Drug: Dexmedetomidine