The Influence of Age on Dexmedetomidine Pharmacodynamic

NCT ID: NCT02099253

Last Updated: 2014-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

120 patients scheduled to undergo lower extremity surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg, in the youth,and middle-aged group. The initial doses of DEX was 0.7 μg/kg,also with dose adjustment intervals of 0.05μg/kg.Sedative efficacy was defined as an OAA/S of ≤2, or an OAA/S of 3 but with an BIS value of ≤46, 26 min after the beginning of drug administration.

Conditions

Spinal Anesthesia

Keywords

Age; Pharmacodynamics; dexmedetomidine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Youth Group

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

Group Type: EXPERIMENTAL

Dexmedetomidine 01

Intervention Type: DRUG

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

Middle-aged Group

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

Group Type: EXPERIMENTAL

Dexmedetomidine 01

Intervention Type: DRUG

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

Older Group

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

Group Type: EXPERIMENTAL

Dexmedetomidine 02

Intervention Type: DRUG

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

Interventions

Dexmedetomidine 01

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

Intervention Type: DRUG

Dexmedetomidine 02

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

Intervention Type: DRUG

Eligibility 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:18.5～25

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: lead

Responsible Party

bo xu

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 20498772 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16037147 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28991112 (View on PubMed)

Other Identifiers

DEX Pharmacodynamics

Identifier Type: -

Identifier Source: org_study_id