A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

NCT ID: NCT03800641

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2020-01-23

Brief Summary

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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

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Conditions

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Anxiety Preoperative Care Pharmacokinetics Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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oral administration

oral administration of dexmedetomidine 4μg/kg

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

oral, intravenous and nasal administration of Dexmedetomidine

intravenous administration

intravenous administration of dexmedetomidine 0.8μg/kg

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

oral, intravenous and nasal administration of Dexmedetomidine

nasal administration

nasal administration of dexmedetomidine 1μg/kg

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

oral, intravenous and nasal administration of Dexmedetomidine

Interventions

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Dexmedetomidine

oral, intravenous and nasal administration of Dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Jinhong Wu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eye, Ear, Nose and Throat Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Wu J, Han Y, Lu Y, Zhuang Y, Li W, Jia J. Perioperative Low Dose Dexmedetomidine and Its Effect on the Visibility of the Surgical Field for Middle Ear Microsurgery: A Randomised Controlled Trial. Front Pharmacol. 2022 Feb 8;13:760916. doi: 10.3389/fphar.2022.760916. eCollection 2022.

Reference Type DERIVED
PMID: 35211010 (View on PubMed)

Other Identifiers

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EyeEntFudan

Identifier Type: -

Identifier Source: org_study_id

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