The Influence of Age on Dexmedetomidine Pharmacodynamic

December 11, 2014 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command

The Influence of Age on Dexmedetomidine Pharmacodynamic in Lower Extremity Surgery

Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the FDA only for short-time sedation during mechanical ventilation of adult patients (<24h) in ICU. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age and gender,such as the drug sensitivity of propofol and remifentanil is increased with age,while the current study also demonstrated that gender may influence the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim to explore the right DEX dose of different Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the BIS,during the operation.The relation between BIS values and the depth of sedation for patients is also investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

120 patients scheduled to undergo lower extremity surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Guangzhou Military Region General Hospital, Department of Anesthesiology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.5～25

Exclusion Criteria:

  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. People who were language or hearing impaired
  5. Sensory block reached to T8 or higher.
  6. People who had lung infection or sleep apnea syndrome.
  7. Pregnancy
  8. Chronic renal failure
  9. Alcohol or drug abuse
  10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

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: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Youth Group
People in this group, aged 18~39,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
Drug: Dexmedetomidine 01
Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
EXPERIMENTAL: Middle-aged Group
People in this group, aged 40~64,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
Drug: Dexmedetomidine 01
Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
EXPERIMENTAL: Older Group
People in this group, aged 65~80,were accepted an initial dose of 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.
Drug: Dexmedetomidine 02
Initial doses was 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The ED50 of DEX
Time Frame: 26min after the start of the infusion
The aim of our study is to define the median effective sedative doses (ED50s) of DEX to determine the effect of age on the pharmacodynamic of DEX in lower extremity surgery using the Dixon and Mood up-and-down method。
26min after the start of the infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The ED95 of DEX
Time Frame: 26min after the start of the infusion
To determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in lower limb orthopedic surgery.
26min after the start of the infusion

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou General Hospital of Guangzhou Military Command

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEX Pharmacodynamics

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