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

July 29, 2016 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou Military Region General Hospital, Department of Anesthesiology
        • Contact:
        • Principal Investigator:
          • Yun Bi Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
patients in group 1, aged 20~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min.
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
Other Names:
  • Dexmedetomidine 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
Other Names:
  • Dexmedetomidine 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
Other Names:
  • Dexmedetomidine 1.1 µg/kg
Experimental: group 2
patients in group 2, aged 20~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min.
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
Other Names:
  • Dexmedetomidine 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
Other Names:
  • Dexmedetomidine 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
Other Names:
  • Dexmedetomidine 1.1 µg/kg
Experimental: group 3
patients in group 3, aged 20~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min.
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
Other Names:
  • Dexmedetomidine 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
Other Names:
  • Dexmedetomidine 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
Other Names:
  • Dexmedetomidine 1.1 µg/kg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The calculated cutoff values for OAA/S≤ 2
Time Frame: at 5-minute intervals until 30 minutes after administration
at 5-minute intervals until 30 minutes after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

July 24, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Narcotrend index

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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