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

Sedative Withdrawal Delirium Clinical Trial

Official title:

The Psychological Effects of Different Sedation Protocol on Mechanically Ventilated Critically Ill adults-a Prospective, Randomized and Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02123589
• Other study ID #: West ChinaH Sedation
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 22, 2014
• Last updated: April 23, 2014
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Sedative Withdrawal Delirium

Intervention

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
• 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
• 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;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incident rate of delirium		From weaning to discharged from ICU,about 7 days.	No
Primary	The incident rates of PTSD		30th day and 180th day after discharged from ICU	No
Primary	The duration of delirium		From weaning to discharged from ICU,about 7 days.	No
Secondary	Incidence rate of unexpected extubation		From intubation to weaning,about 7 days	No
Secondary	Dosage of analgesics and sedatives		From intination of analgesics and sedatives to stopping drug appication,about 7 days	No
Secondary	The duration of mechanical ventilation		From intubation to weaning,about 7days	No
Secondary	Duration of ICU		From admitted to ICU to discharged from ICU,about 7 days	No
Secondary	The whole hospitalization time		From admitted to hospital to discharged from hospital,about 7 days	No
Secondary	Patients' death rates within ICU stay		From admitted to ICU to discharged from ICU,about 7 days	No
Secondary	Patients' death rates within hospitalized stay		From admitted to hospital to discharged from hospital,about 7 days	No
Secondary	The cost in ICU		From admitted to ICU to discharged from ICU,about 7 days	No
Secondary	The total cost in hospital		From admitted to hospital to discharged from hospital,about 7 days	No