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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02773017
Enrollment
90
Registered
2016-05-16
Start date
2016-06-30
Completion date
2016-10-31
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combined Spinal-epidural Anesthesia

Keywords

sedation, age, dexmedetomidine

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.

Detailed 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.

Interventions

DRUGDexmedetomidine 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.

DRUGDexmedetomidine 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.

DRUGDexmedetomidine 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.

Sponsors

Guangzhou General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 79 Years
Healthy volunteers
No

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:18.0~25.0kg/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 \- \-

Design outcomes

Primary

MeasureTime frameDescription
The ED50 of DEX for providing sedation30min after the start of the infusionThe 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。

Secondary

MeasureTime frameDescription
The ED95 of DEX30min after the start of the infusionTo determine the optimum bolus dose (ED95) of dexmedetomidine for producing adequate sedation during spinal anesthesia in different female age group.

Countries

China

Contacts

Primary ContactBo Xu
xubo333@hotmail.com88653387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026