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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02845661
Enrollment
60
Registered
2016-07-27
Start date
2016-06-30
Completion date
2016-09-30
Last updated
2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Narcotrend index, OAA/S scale, Dexmedetomidine, Sedation

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).

Interventions

DRUGDexmedetomidine

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

Sponsors

Guangzhou General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the correlation coefficient between OAA/S scale and Narcotrend index in group 1at 5-minute intervals until 30 minutes after administrationThis 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 2at 5-minute intervals until 30 minutes after administrationThis 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 3at 5-minute intervals until 30 minutes after administrationThis 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

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

Countries

China

Contacts

Primary Contactbo Xu
xubo333@hotmail.com88653387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026