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

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02845661
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-24
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-27
• Last Update Submitted: 2016-07-29
• Last Update Posted: 2016-08-01
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25 kg/m2

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Exclusion Criteria

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	Dexmedetomidine	patients in group 2, aged 20\~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min.
group 3	Dexmedetomidine	patients in group 3, aged 20\~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min.
group 1	Dexmedetomidine	patients in group 1, aged 20\~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min.

Primary Outcome Measures

Name	Time	Method
the correlation coefficient between OAA/S scale and Narcotrend index in group 1	at 5-minute intervals until 30 minutes after administration	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.
the correlation coefficient between OAA/S scale and Narcotrend index in group 2	at 5-minute intervals until 30 minutes after administration	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.
the correlation coefficient between OAA/S scale and Narcotrend index in group 3	at 5-minute intervals until 30 minutes after administration	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.

Secondary Outcome Measures

Name	Time	Method
The calculated cutoff values for OAA/S≤ 2	at 5-minute intervals until 30 minutes after administration

Trial Locations

Locations (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology; 🇨🇳 Guangzhou, Guangdong, China