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

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What is being tested

Dexmedetomidine

Drug
Who is being recruted

From 20 to 60 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2016
See protocol details

Summary

Principal SponsorGuangzhou General Hospital of Guangzhou Military Command
Study Contactbo Xu
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

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).

Official TitleThe Correlation of Narcotrend Index and OAA/S Scale in Monitoring Sedation Level With Different Doses of Dexmedetomidine
NCT02845661
Principal SponsorGuangzhou General Hospital of Guangzhou Military Command
Study Contactbo Xu
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
Written informed consent from the patient or the relatives of the participating patient.
BMI:18.0～25 kg/m2
6 exclusion criteria prevent from participating
Alcohol or drug abuse
Chronic renal failure
Mental illness can not match
epidural anesthesia contraindicated
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
patients in group 1, aged 20\~60, were accepted an initial dose of 0.9μg/kg dexmedetomidine over 15 min.

Group II

Experimental
patients in group 2, aged 20\~60, were accepted an initial dose of 1.0μg/kg dexmedetomidine over 15 min.

Group III

Experimental
patients in group 3, aged 20\~60, were accepted an initial dose of 1.1μg/kg dexmedetomidine over 15 min.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, ChinaOpen Guangzhou Military Region General Hospital, Department of Anesthesiology in Google Maps
SuspendedOne Study Center