NCT03480789

Brief 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.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

February 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 18, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

March 29, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

March 18, 2018

Last Update Submit

March 26, 2018

Conditions

Metabolic ProblemsSleep

Outcome Measures

Primary Outcomes (1)

  • the total time of sleep

    using EEG records the time of sleep and different sleep phases

    the first 24hours in the icu

Study Arms (4)

eye patch

EXPERIMENTAL

wearing the eye patch from 22:00 to 6:00 of the next day

Device: eye patch

Dexmedetomidine

EXPERIMENTAL

given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day

Drug: Dexmedetomidine

eye patch + DEX

EXPERIMENTAL

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

Drug: DexmedetomidineDevice: eye patch

usual treatment

NO INTERVENTION

treatment as usual

Interventions

DexmedetomidineDRUG

given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day

Also known as: Precedex
Dexmedetomidineeye patch + DEX
eye patchDEVICE

wearing the eye patch from 22:00 to 6:00 of the next day

Also known as: blinders
eye patcheye patch + DEX

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant or breastfeeding
  • sleep disorders before operation
  • poor liver or kidney function
  • post craniocerebral operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Wenkui Yu, Ph.D

CONTACT

02568182222yudrnj@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 29, 2018

Study Start

February 5, 2018

Primary Completion

June 30, 2018

Study Completion

July 31, 2018

Last Updated

March 29, 2018

Record last verified: 2018-01

Locations

CN(1)