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The ED50 of DEX for Providing Sedation in Different Female Age Group

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ClinicalTrials.gov Identifier: NCT02773017
Recruitment Status : Unknown
Verified June 2016 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Combined Spinal-epidural Anesthesia Drug: Dexmedetomidine A Drug: Dexmedetomidine B Drug: Dexmedetomidine C Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

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Arms and Interventions
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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.
 Drug: Dexmedetomidine A
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 Name: Dexmedetomidne in youth female group
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.
 Drug: Dexmedetomidine B
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 Name: Dexmedetomiodine in middle-age female group
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.
 Drug: Dexmedetomidine C
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 Name: Dexmedetomidine in elderly female group


Outcome Measures
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Primary Outcome Measures :
  1. The ED50 of DEX for providing sedation [ Time Frame: 30min after the start of the infusion ]
    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。


Secondary Outcome Measures :
  1. The ED95 of DEX [ Time Frame: 30min after the start of the infusion ]
    To determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in different female age group.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:18.0～25.0kg/m2

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

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Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773017


Contacts
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Contact: Bo Xu 88653387 ext 020 xubo333@hotmail.com

Locations
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China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, China, 510010
Contact: Yun Bi Chen    15622131984 ext 86    645632618@qq.com   
Principal Investigator: Yun Bi Chen         
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
More Information
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Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02773017    
Other Study ID Numbers: DEX sedation
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Keywords provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:
sedation
age
dexmedetomidine
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action