PatientsVille.com LogoPatientsVille.com

Sedative Withdrawal Delirium | The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill Adults.

Sedative Withdrawal Delirium research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sedative Withdrawal Delirium

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug: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

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

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;

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Deep sedationInjection 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 sedationInjection 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 sedationInjection 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.

Study Status

Unknown status

Start Date: April 2014

Completed Date: December 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: The incident rate of delirium

Secondary Outcome: Incidence rate of unexpected extubation

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: West China Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02123589

Discuss Sedation