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

Sichuan University

Status and phase: Unknown; Phase 4

Conditions: Sedative Withdrawal Delirium

Treatments: Drug: Deep and daily interruption of sedation(midazolam and fentanyl ); Drug: Deep sedation(midazolam and fentanyl ); Drug: Light sedation(midazolam and fentanyl )

Study type: Interventional

Funder types: Other

Identifiers

NCT02123589

West ChinaH Sedation

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Deep sedation

Experimental group

Description:

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

Treatment:

Drug: Deep sedation(midazolam and fentanyl )

Deep and daily interruption of sedation

Experimental group

Description:

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 .

Treatment:

Drug: Deep and daily interruption of sedation(midazolam and fentanyl )

Light sedation

Experimental group

Description:

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.

Treatment:

Drug: Light sedation(midazolam and fentanyl )