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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sedative Withdrawal Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Deep sedation

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

Group Type EXPERIMENTAL

Deep sedation(midazolam and fentanyl )

Intervention Type DRUG

0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3

Deep and daily interruption of sedation

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 .

Group Type EXPERIMENTAL

Deep and daily interruption of sedation(midazolam and fentanyl )

Intervention Type DRUG

0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU

Light sedation

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.

Group Type EXPERIMENTAL

Light sedation(midazolam and fentanyl )

Intervention Type DRUG

0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;

Interventions

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Deep sedation(midazolam and fentanyl )

0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3

Intervention Type DRUG

Deep and daily interruption of sedation(midazolam and fentanyl )

0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU

Intervention Type DRUG

Light sedation(midazolam and fentanyl )

0.05\~0.1mg/kg midazolam and 1\~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1\~2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No