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NCT Number: NCT03800641

A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation

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.

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Key information

Conditions

Anxiety Anxiety Disorders Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacokinetics Postoperative Complications Preoperative Care Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye, Ear, Nose and Throat Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

oral, intravenous and nasal administration of Dexmedetomidine

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effect of sedation

    Time frame: 10min after administration

    Evaluated with Ramsay sedation scale Score Response

    • Anxious or restless or both
    • Cooperative, orientated and tranquil
    • Responding to commands
    • Brisk response to stimulus
    • Sluggish response to stimulus
    • No response to stimulus

  2. 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.

    • Slight bleeding - no suctioning of blood required.
    • Slight bleeding - occasional suctioning required. Surgical field not threatened.
    • Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
    • Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.
    • Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 11, 2019
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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