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

NCT02773017 | Unknown Phase 4

• 1 other identifier: DEX sedation
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Combined Spinal-epidural Anesthesia

Keywords

sedation; age; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• The ED50 of DEX for providing sedation

  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。

  30min after the start of the infusion

Secondary Outcomes (1)

• The ED95 of DEX

  30min after the start of the infusion

Study Arms (3)

Youth female group

EXPERIMENTAL

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

Middle-aged female group

EXPERIMENTAL

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

Elderly female group

EXPERIMENTAL

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

Interventions

Dexmedetomidine A 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.

Also known as: Dexmedetomidne in youth female group

Youth female group

Dexmedetomidine B 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.

Also known as: Dexmedetomiodine in middle-age female group

Middle-aged female group

Dexmedetomidine C 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.

Also known as: Dexmedetomidine in elderly female group

Elderly female group

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bo Xu

CONTACT

88653387; xubo333@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 16, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

CN (1)