A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

January 7, 2022 updated by: Jinhong Wu, Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Eye, Ear, Nose and Throat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oral administration
oral administration of dexmedetomidine 4μg/kg
Drug: Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine
Active Comparator: intravenous administration
intravenous administration of dexmedetomidine 0.8μg/kg
Drug: Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine
Experimental: nasal administration
nasal administration of dexmedetomidine 1μg/kg
Drug: Dexmedetomidine
oral, intravenous and nasal administration of Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dexmedetomidine pharmacokinetic curve
Time Frame: 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.
120 min DEX pharmacokinetics

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of sedation
Time Frame: 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
10min after administration
Evaluation of surgical field
Time Frame: 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.
30min after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Actual)

March 29, 2019

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EyeEntFudan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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