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

West China Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Sedative Withdrawal Delirium

Interventions

Deep sedation(midazolam and fentanyl )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(midazolam and fentanyl )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(midazolam and fentanyl )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;

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incident rate of delirium

Time frame: From weaning to discharged from ICU,about 7 days.

The incident rates of PTSD

Time frame: 30th day and 180th day after discharged from ICU

The duration of delirium

Time frame: From weaning to discharged from ICU,about 7 days.

Secondary Outcomes

Incidence rate of unexpected extubation

Time frame: From intubation to weaning,about 7 days

Dosage of analgesics and sedatives

Time frame: From intination of analgesics and sedatives to stopping drug appication,about 7 days

The duration of mechanical ventilation

Time frame: From intubation to weaning,about 7days

Duration of ICU

Time frame: From admitted to ICU to discharged from ICU,about 7 days

The whole hospitalization time

Time frame: From admitted to hospital to discharged from hospital,about 7 days

Patients' death rates within ICU stay

Time frame: From admitted to ICU to discharged from ICU,about 7 days

Patients' death rates within hospitalized stay

Time frame: From admitted to hospital to discharged from hospital,about 7 days

The cost in ICU

Data from ClinicalTrials.gov

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