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Clinical Trials/NCT03480789
NCT03480789UnknownNot Applicable

the Influence of Sleep Improvement Through Different Methods on Patients in ICU

Chinese Medical Association1 site in 1 country120 target enrollmentStarted: February 5, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
120
Locations
1
Primary Endpoint
the total time of sleep

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

eye patch

Experimental

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

Intervention: eye patch (Device)

Dexmedetomidine

Experimental

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

Intervention: Dexmedetomidine (Drug)

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

Intervention: Dexmedetomidine (Drug)

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

Intervention: eye patch (Device)

Outcomes

Primary Outcomes

the total time of sleep

Time Frame: the first 24hours in the icu

using EEG records the time of sleep and different sleep phases

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (1)

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