A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

Phase 4

Completed

• Conditions: Anxiety; Pharmacokinetics; Preoperative Care; Emergence Delirium
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03800641
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-09
• Study Start: 2019-01-11
• Study First Posted: 2019-01-11
• Primary Completion: 2019-03-29
• Study Completion: 2020-01-23
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral administration	Dexmedetomidine	oral administration of dexmedetomidine 4μg/kg
intravenous administration	Dexmedetomidine	intravenous administration of dexmedetomidine 0.8μg/kg
nasal administration	Dexmedetomidine	nasal administration of dexmedetomidine 1μg/kg

Primary Outcome Measures

Name	Time	Method
Dexmedetomidine pharmacokinetic curve	120 min DEX pharmacokinetics	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

Name	Time	Method
Effect of sedation	10min after administration	Evaluated with Ramsay sedation scale Score Response; 1. Anxious or restless or both; 2. Cooperative, orientated and tranquil; 3. Responding to commands; 4. Brisk response to stimulus; 5. Sluggish response to stimulus; 6. No response to stimulus
Evaluation of surgical field	30min after administration	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.; 1. Slight bleeding - no suctioning of blood required.; 2. Slight bleeding - occasional suctioning required. Surgical field not threatened.; 3. Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.; 4. Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.; 5. Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.

Trial Locations

Locations (1)

Eye, Ear, Nose and Throat Hospital; 🇨🇳 Shanghai, Shanghai, China