The Influence of Age on Dexmedetomidine Pharmacodynamic

Spinal Anesthesia Clinical Trial

Official title:

The Influence of Age on Dexmedetomidine Pharmacodynamic in Lower Extremity Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099253
• Other study ID #: DEX Pharmacodynamics
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2014
• Last updated: December 11, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. ASA ? ~ ? 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Anesthesia

Intervention

Drug:
• Dexmedetomidine 01
Initial doses was 1µg/kg, with dose adjustment intervals of 0.05µg/kg.
• Dexmedetomidine 02
Initial doses was 0.7µg/kg, with dose adjustment intervals of 0.05µg/kg.

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (2)

Kodaka M, Johansen JW, Sebel PS. The influence of gender on loss of consciousness with sevoflurane or propofol. Anesth Analg. 2005 Aug;101(2):377-81, table of contents. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The ED95 of DEX	To determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in lower limb orthopedic surgery.	26min after the start of the infusion	No