The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.

Phase 4

• Conditions: Sedative Withdrawal Delirium
• Interventions: Drug: Deep sedation(midazolam and fentanyl ); Drug: Deep and daily interruption of sedation(midazolam and fentanyl ); Drug: Light sedation(midazolam and fentanyl )

• Registration Number: NCT02123589
• Lead Sponsor: West China Hospital

Brief Summary

The study was designed to explore the effects of different sedation protocol on incidence rates of delirium and PTSD in severe patients with mechanically ventilation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-23
• Last Update Submitted: 2014-04-23
• Study First Posted: 2014-04-25
• Last Update Posted: 2014-04-25
• Primary Completion: 2015-05
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Written informed consent
• Critically ill adults whose expected time of mechanical ventilation is longer than 24 hours
• Aged between 18 years old to 85 years old.

Exclusion Criteria

• Subjects with brain injury;
• History of cardiopulmonary resuscitation;
• Mental disability;
• Taken neuromuscular blocking drugs;
• Inability to exchange;
• Contraindicated to midazolam or morphine;
• Inconvenience to daily interruption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep sedation	Deep sedation(midazolam and fentanyl )	Injection of 0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3
Deep and daily interruption of sedation	Deep and daily interruption of sedation(midazolam and fentanyl )	Injection of 0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -5 and -3.and from the second day after subject was admitted in ICU, daily interruption of sedation will be taken .
Light sedation	Light sedation(midazolam and fentanyl )	Injection of 0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,then continuous intravenous infusion 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl to maintain sedation until attaining the target level of sedation,RASS score between -2 and +1.

Primary Outcome Measures

Name	Time	Method
The incident rate of delirium	From weaning to discharged from ICU,about 7 days.
The incident rates of PTSD	30th day and 180th day after discharged from ICU
The duration of delirium	From weaning to discharged from ICU,about 7 days.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of unexpected extubation	From intubation to weaning,about 7 days
Dosage of analgesics and sedatives	From intination of analgesics and sedatives to stopping drug appication,about 7 days
The duration of mechanical ventilation	From intubation to weaning,about 7days
Duration of ICU	From admitted to ICU to discharged from ICU,about 7 days
The whole hospitalization time	From admitted to hospital to discharged from hospital,about 7 days
Patients' death rates within ICU stay	From admitted to ICU to discharged from ICU,about 7 days
Patients' death rates within hospitalized stay	From admitted to hospital to discharged from hospital,about 7 days
The cost in ICU	From admitted to ICU to discharged from ICU,about 7 days
The total cost in hospital	From admitted to hospital to discharged from hospital,about 7 days