Clinical trial NCT02845661: Correlation of Narcotrend Index and the Observer's Assessment of Alertness/Sedation (OAA/S) Scale
Official title: The Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: Narcotrend index
OAA/S scale
Dexmedetomidine
Sedation
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

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

Primary outcomes:
measure: the correlation coefficient between OAA/S scale and Narcotrend index in group 1
timeFrame: at 5-minute intervals until 30 minutes after administration
measure: the correlation coefficient between OAA/S scale and Narcotrend index in group 2
timeFrame: at 5-minute intervals until 30 minutes after administration
measure: the correlation coefficient between OAA/S scale and Narcotrend index in group 3
timeFrame: at 5-minute intervals until 30 minutes after administration
Secondary outcomes:
measure: The calculated cutoff values for OAA/S≤ 2
timeFrame: at 5-minute intervals until 30 minutes after administration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References: