Acceptable Hemodynamic Changes in Dexmedetomidine for Single Intravenous Bolus Injection

September 23, 2019 updated by: Second Affiliated Hospital of Wenzhou Medical University

Determination of ED50 and ED95 of Single Bolus Dexmedetomidine in General Anesthesia Patients to Produce Acceptable Hemodynamic Outcomes

Dexmedetomidine（DEX）is a potent and highly selective α 2 adrenergic receptor agonist. It has the pharmacological effects of sedation, hypnosis, analgesia, anti-sympathetic and neuroprotective. Its sedative effect is similar to normal sleep, and easy to wake up. DEX is widely used clinically because of its advantages and acceptable side effects. The best clinical use of DEX is uncertain, including intravenous, intramuscular, oral, intralnasal and sublingual administration. Its clinical recommended use is intravenous load infusion for more than 10 minutes, followed by continuous infusion. However, the clinical recommended usage is inconvenient, time-consuming and other shortcomings, for the growing popularity of daytime surgery, will inevitably affect the operation process and turnover. If a suitable dose range of DEX can be found for a single intravenous injection to achieve clinical efficacy quickly without significant hemodynamic effects, this will improve the patient's postoperative recovery. We will speed up the utilization and turnover of medical resources. The aim of this study was to investigate the optimal dosage of DEX for single intravenous injection.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Detailed Description

Patients undergoing thyroidectomy under general anesthesia were treated with routine anesthesia induction and maintenance, and DEX was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of DEX was 0.1 ug/kg. If the cardiovascular reaction was positive (MAP or heart rate was more than 20% before intravenous injection), the dosage of DEX in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of DEX by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew. There were 8 turning points of cardiovascular reaction and the test was completed. The changes of blood pressure and heart rate per minute in 10min were recorded after single bolus. The dosimetric map of patients with DEX was drawn, and the ED50 and ED95 were calculated by probit probabilistic unit regression (Bills method).

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 (Anticipated)

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.
42

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chengyu Wang

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 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. volunteer to participate in the study and sign the informed consent;
  2. selective operation of thyroid gland whose anesthesia time is less than 2 hours ;
  3. aged 18-55 years;
  4. ASA I - II;
  5. BMI 18~28kg/m2.

Exclusion Criteria:

  1. Mallampati grade Ⅲ or Ⅳ;
  2. opening degree < 2.5 cm;
  3. taking analgesic or sedative drugs for a long time before operation;
  4. a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on;
  5. allergic to dexmedetomidine, similar active ingredients or excipients;
  6. G-6-PD deficiency;
  7. a history of use of alpha 2 receptor agonists or antagonists.

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: NA
  • Interventional Model: SINGLE_GROUP
  • 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: Dexmedetomidine
Drug: Dexmedetomidine dexmedetomidine, 0.1ug/kg up or down Other Name: precedex
Drug: Dexmedetomidine
Dexmedetomidine was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of dexmedetomidine was 0.1 ug/kg. If the cardiovascular reaction was positive (mean arterial pressure or heart rate was more than 20% before intravenous injection), the dosage of Dexmedetomidine in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of dexmedetomidine by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew.
Other Names:
  • see arms

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
Heart rate(HR)
Time Frame: 10min
HR changes per minutes in 10 minutes after single injection of DEX
10min

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
Duration of operation
Time Frame: intraoperative, from the beginning of the cut to the end of the seam
Duration of operation
intraoperative, from the beginning of the cut to the end of the seam
Anaesthesia time
Time Frame: intraoperative, from initiation of anesthesia induction to cessation of anesthetic use
Anaesthesia time
intraoperative, from initiation of anesthesia induction to cessation of anesthetic use
Recovery time of anesthesia
Time Frame: within 24 hours
Recovery time of anesthesia
within 24 hours
Mean arterial pressure(MAP)
Time Frame: 10min
MAP changes per minutes in 10 minutes after single injection of DEX
10min

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.
Second Affiliated Hospital of Wenzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jun Li, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

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)

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.
May 23, 2018

Primary Completion (ANTICIPATED)

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.
March 23, 2020

Study Completion (ANTICIPATED)

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.
April 23, 2020

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).
July 2, 2018

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.
August 30, 2018

First Posted (ACTUAL)

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.
August 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

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.
September 25, 2019

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.
September 23, 2019

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.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • LCKY2018-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be available.

IPD Sharing Time Frame

Data will be available within 6 months of study complettion.

IPD Sharing Access Criteria

Data access request will be reviewed by an external independent review panel.Requestors will be required to sign a Data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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