NCT03800641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_4 anxiety

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 7, 2019

Last Update Submit

January 7, 2022

Conditions

AnxietyPreoperative CarePharmacokineticsEmergence Delirium

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Effect of sedation

    10min after administration

  • Evaluation of surgical field

    30min after administration

Study Arms (3)

oral administration

EXPERIMENTAL

oral administration of dexmedetomidine 4μg/kg

Drug: Dexmedetomidine

intravenous administration

ACTIVE COMPARATOR

intravenous administration of dexmedetomidine 0.8μg/kg

Drug: Dexmedetomidine

nasal administration

EXPERIMENTAL

nasal administration of dexmedetomidine 1μg/kg

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

oral, intravenous and nasal administration of Dexmedetomidine

intravenous administrationnasal administrationoral administration

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • participants who undergo tympanoplasty would be enrolled after signment the informed consent.

You may not qualify if:

  • The participants were excluded with any diseases about respiration, circulation, liver and kidney.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye, Ear, Nose and Throat Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

  • 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.

    PMID: 35211010DERIVED

MeSH Terms

Conditions

Anxiety DisordersEmergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 11, 2019

Study Start

January 11, 2019

Primary Completion

March 29, 2019

Study Completion

January 23, 2020

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CN(1)