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

NCT02123589 | Unknown Phase 4

• 1 other identifier: West ChinaH Sedation
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sedative Withdrawal Delirium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (3)

Deep sedation

EXPERIMENTAL

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

Drug: Deep sedation(midazolam and fentanyl )

Deep and daily interruption of sedation

EXPERIMENTAL

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 .

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

Light sedation

EXPERIMENTAL

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.

Drug: Light sedation(midazolam and fentanyl )

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 sedation

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

Deep and daily interruption of sedation

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;

Light sedation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 25, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2014

Record last verified: 2014-04