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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845661
• Other study ID #: Narcotrend index
• Status: Recruiting
• Phase: Phase 4
• First received: July 24, 2016
• Last updated: July 29, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: bo Xu
• Phone: 88653387
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. ASA ? ~ ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	The calculated cutoff values for OAA/S= 2		at 5-minute intervals until 30 minutes after administration	Yes