The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Deep sedation(midazolam and fentanyl )
- Conditions
- Sedative Withdrawal Delirium
- Sponsor
- West China Hospital
- Enrollment
- 150
- Primary Endpoint
- The incident rate of delirium
- Last Updated
- 12 years ago
Overview
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.
Investigators
Kangyan
Physician
West China Hospital
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Deep sedation(midazolam and fentanyl )
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 .
Intervention: Deep and daily interruption of sedation(midazolam and fentanyl )
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.
Intervention: Light sedation(midazolam and fentanyl )
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(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)
- Patients' death rates within ICU stay(From admitted to ICU to discharged from ICU,about 7 days)
- Patients' death rates within hospitalized stay(From admitted to hospital to discharged from hospital,about 7 days)
- The cost in ICU(From admitted to ICU to discharged from ICU,about 7 days)
- The total cost in hospital(From admitted to hospital to discharged from hospital,about 7 days)