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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03480789
Other study ID # sleep in ICU
Secondary ID
Status Recruiting
Phase N/A
First received March 18, 2018
Last updated March 26, 2018
Start date February 5, 2018
Est. completion date July 31, 2018

Study information

Verified date January 2018
Source Chinese Medical Association
Contact Wenkui Yu, Ph.D
Phone 02568182222
Email yudrnj@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected.


Description:

In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected. The research aims to confirm that the sleep quality could have a great influence on patients in the ICU and different interventions would make various changes.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- the postoperative patients that admission to icu is more than 48h

Exclusion Criteria:

- pregnant or breastfeeding

- sleep disorders before operation

- poor liver or kidney function

- post craniocerebral operation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day
Device:
eye patch
wearing the eye patch from 22:00 to 6:00 of the next day

Locations

Country Name City State
China The Affliated Drum Tower Hospital, Medical School of Nanjing University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the total time of sleep using EEG records the time of sleep and different sleep phases the first 24hours in the icu
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