Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale

Study Overview
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Brief Summary
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Narcotrend index is a widely used quantitative parameter for evaluating anesthesia and sedation levels.Dexmedetomidine is a novel sedative,providing sedation while patients remain cooperative and can be easily aroused. This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of dexmedetomidine intravenously.

Detailed Description
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60 patients,aged 20～60,American Society of Anesthesiologists (ASA) physical status ⅠorⅡ, scheduled for electively lower limb surgery undergoing combined spinal epidural anesthesia were randomly divided three group. In each group,a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia. The initial dose in group 1, group 2 and group 3 was started from 0.9 µg/kg,1.0 µg/kg and 1.1 µg/kg, respectively. HR、MAP、SpO2、the Observer's Assessment of Alertness/Sedation（OAA/S）scale and the corresponding Narcotrend index were recorded at 5-minute intervals until 30 minutes after administration. The relationship between OAA/S scale and Narcotrend index was analyzed by a Spearman analysis. The cutoff values of Narcotrend index for OAA/S≤2 were obtained by analysis of receiver operating characteristic curves(ROC).

Official Title
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The Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Ⅰ   Ⅱ women undergoing Laparoscopic surgery. Written informed consent from the patient or the relatives of the participating patient. BMI:18.0～25 kg/m2 Exclusion Criteria: Mental illness can not match epidural anesthesia contraindicated People who have Slow-type arrhythmias Chronic renal failure Alcohol or drug abuse Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>patients in group 1, aged 20 60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min. | Drug: Dexmedetomidine<br>* a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 1 was started from 0.9 µg/kg<br>* Other names: Dexmedetomidine 0.9 µg/kg;|
| Experimental: group 2<br>patients in group 2, aged 20 60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min. | Drug: Dexmedetomidine<br>* a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 2 was started from 1.0 µg/kg<br>* Other names: Dexmedetomidine 1.0 µg/kg;|
| Experimental: group 3<br>patients in group 3, aged 20 60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min. | Drug: Dexmedetomidine<br>* a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 3 was started from 1.1 µg/kg<br>* Other names: Dexmedetomidine 1.1 µg/kg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation coefficient between OAA/S scale and Narcotrend index in group 1 | This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 0.9 μg/kg dexmedetomidine intravenously. | at 5-minute intervals until 30 minutes after administration | 
| the correlation coefficient between OAA/S scale and Narcotrend index in group 2 | This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.0 μg/kg dexmedetomidine intravenously. | at 5-minute intervals until 30 minutes after administration | 
| the correlation coefficient between OAA/S scale and Narcotrend index in group 3 | This study was designed to explore the correlation of Narcotrend index and OAA/S scale in monitoring sedation level with different single- doses of 1.1 μg/kg dexmedetomidine intravenously. | at 5-minute intervals until 30 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The calculated cutoff values for OAA/S≤ 2 |  | at 5-minute intervals until 30 minutes after administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcotrend index, OAA/S scale, Dexmedetomidine, Sedation