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

Combined Spinal-epidural Anesthesia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02773017
• Other study ID #: DEX sedation
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 11, 2016
• Last updated: June 16, 2016
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Bo Xu
• Phone: 88653387
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 79 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:18.0~25.0kg/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

Study Design

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

Related Conditions & MeSH terms

• Combined Spinal-epidural Anesthesia

Intervention

Drug:
• 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.
• 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.
• 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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The ED95 of DEX	To determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in different female age group.	30min after the start of the infusion	No