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

NCT ID: NCT02773017

Last Updated: 2016-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Combined Spinal-epidural Anesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine A

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Dexmedetomidine B

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Dexmedetomidine C

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidne in youth female group Dexmedetomiodine in middle-age female group Dexmedetomidine in elderly female group

Eligibility Criteria

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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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Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

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bo xu

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Bo Xu

Role: CONTACT

88653387 ext. 020

Facility Contacts

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Yun Bi Chen

Role: primary

15622131984 ext. 86

Other Identifiers

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DEX sedation

Identifier Type: -

Identifier Source: org_study_id

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