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

Not Applicable

• Conditions: Sleep; Metabolic Problems
• Interventions: Device: eye patch; Drug: Dexmedetomidine

• Registration Number: NCT03480789
• Lead Sponsor: Chinese Medical Association

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 Timeline

• Status Verified: 2018-01
• Study Start: 2018-02-05
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Study First Posted: 2018-03-29
• Last Update Posted: 2018-03-29
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eye patch	eye patch	wearing the eye patch from 22:00 to 6:00 of the next day
Dexmedetomidine	Dexmedetomidine	given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day
eye patch + DEX	eye patch	given dexmedetomidine to meet RASS -1 and wearing the eye patch from 22:00 to 6:00 of the next day
eye patch + DEX	Dexmedetomidine	given dexmedetomidine to meet RASS -1 and wearing the eye patch from 22:00 to 6:00 of the next day

Primary Outcome Measures

Name	Time	Method
the total time of sleep	the first 24hours in the icu	using EEG records the time of sleep and different sleep phases

Trial Locations

Locations (1)

The Affliated Drum Tower Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China