- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02773017
The ED50 of DEX for Providing Sedation in Different Female Age Group
June 16, 2016 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command
Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects.
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 current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare.
This study was designed to explore the right DEX dose of different female 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 Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups.
In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.
Study Type
Interventional
Enrollment (Anticipated)
90
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
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Guangdong
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Guangzhou, Guangdong, China, 510010
- Guangzhou Military Region General Hospital, Department of Anesthesiology
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Contact:
- Yun Bi Chen
- Phone Number: 86 15622131984
- Email: 645632618@qq.com
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Principal Investigator:
- Yun Bi Chen
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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
20 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18.0~25.0kg/m2
Exclusion Criteria:
- Mental illness can not match
- epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- People who were language or hearing impaired
- Sensory block reached to T8 or higher.
- People who had lung infection or sleep apnea syndrome.
- Pregnancy
- Chronic renal failure
- Alcohol or drug abuse
Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug
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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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Youth female group
patients in the Youth female group, aged 20~35, were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
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initial dose was 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
Other Names:
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Experimental: Middle-aged female group
patients in the Middle-aged female group, aged 40~60, were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
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initial dose was 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
Other Names:
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Experimental: Elderly female group
Patient in the elderly female group, aged 65~79, were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
|
initial dose was 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ED50 of DEX for providing sedation
Time Frame: 30min after the start of the infusion
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The aim of this study is to define the optimum bolus dose (ED50) of dexmedetomidine for producing adequate sedation during spinal anesthesia in different female age group using the Dixon and Mood up-and-down method。
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30min after the start of the infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ED95 of DEX
Time Frame: 30min after the start of the infusion
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To determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in different female age group.
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30min after the start of the infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
June 1, 2016
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (Estimate)
May 16, 2016
Study Record Updates
Last Update Posted (Estimate)
June 17, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- DEX sedation
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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