The Influence of Age on Dexmedetomidine Pharmacodynamic

NCT02099253 | Completed Phase 4

• 1 other identifier: DEX Pharmacodynamics
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine(DEX) is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects .At earlier time It was approved by the FDA only for short-time sedation during mechanical ventilation of adult patients (\<24h) in ICU. 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 gender,such as the drug sensitivity of propofol and remifentanil is increased with age,while the current study also demonstrated that gender may influence the sedate efficacy of propofol and the sensitivity of muscle loose of rocuronium. Current studies with regard to the effects of age and gender on dexmedetomidine pharmacodynamic are rare. The study is aim to explore the right DEX dose of different 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 BIS,during the operation.The relation between BIS values and the depth of sedation for patients is also investigated.

Conditions

Spinal Anesthesia

Keywords

Age; Pharmacodynamics; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• The ED50 of DEX

  The aim of our study is to define the median effective sedative doses (ED50s) of DEX to determine the effect of age on the pharmacodynamic of DEX in lower extremity surgery using the Dixon and Mood up-and-down method。

  26min after the start of the infusion

Secondary Outcomes (1)

• The ED95 of DEX

  26min after the start of the infusion

Study Arms (3)

Youth Group

EXPERIMENTAL

People in this group, aged 18\~39,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg.

Drug: Dexmedetomidine 01

Middle-aged Group

EXPERIMENTAL

People in this group, aged 40\~64,were accepted an initial dose of 1μg/kg, with dose adjustment intervals of 0.05μg/kg.

Drug: Dexmedetomidine 01

Older Group

EXPERIMENTAL

People in this group, aged 65\~80,were accepted an initial dose of 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.

Drug: Dexmedetomidine 02

Interventions

Dexmedetomidine 01 DRUG

Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg.

Middle-aged Group; Youth Group

Dexmedetomidine 02 DRUG

Initial doses was 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.

Older Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• 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:18.5～25

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

Related Publications (3)

• Park SJ, Park HJ, Choi JY, Kang HS, Choi HS. The influence of age and gender on remifentanil EC(50) for preventing rocuronium induced withdrawal movements. Korean J Anesthesiol. 2010 Mar;58(3):244-8. doi: 10.4097/kjae.2010.58.3.244. Epub 2010 Mar 29.

  PMID: 20498772 BACKGROUND

• Kodaka M, Johansen JW, Sebel PS. The influence of gender on loss of consciousness with sevoflurane or propofol. Anesth Analg. 2005 Aug;101(2):377-381. doi: 10.1213/01.ANE.0000154534.71371.4F.

  PMID: 16037147 BACKGROUND

• Xu B, Li Z, Zhou D, Li L, Li P, Huang H. The Influence of Age on Sensitivity to Dexmedetomidine Sedation During Spinal Anesthesia in Lower Limb Orthopedic Surgery. Anesth Analg. 2017 Dec;125(6):1907-1910. doi: 10.1213/ANE.0000000000002531.

  PMID: 28991112 DERIVED

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: March 26, 2014
• First Posted: March 28, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

CN (1)