NCT02845661

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou General Hospital of Guangzhou Military Command · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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
DRUG	Dexmedetomidine	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
DRUG	Dexmedetomidine	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

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-07-27
• Last updated: 2016-08-01

Locations

1 site across 1 country: China