NCT02845661

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 24, 2016

Last Update Submit

July 29, 2016

Conditions

Anesthesia

Keywords

Narcotrend indexOAA/S scaleDexmedetomidineSedation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • The calculated cutoff values for OAA/S≤ 2

    at 5-minute intervals until 30 minutes after administration

Study Arms (3)

group 1

EXPERIMENTAL

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

Drug: Dexmedetomidine

group 2

EXPERIMENTAL

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

Drug: Dexmedetomidine

group 3

EXPERIMENTAL

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

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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

Also known as: Dexmedetomidine 0.9 µg/kg
group 1

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Mental illness can not match
  • epidural anesthesia contraindicated
  • People who have Slow-type arrhythmias
  • Chronic renal failure
  • Alcohol or drug abuse
  • Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

bo Xu

CONTACT

88653387xubo333@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

July 24, 2016

First Posted

July 27, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

CN(1)