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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sedative Withdrawal Delirium
• Intervention / Treatment: Drug: Deep sedation(midazolam and fentanyl ); Drug: Deep and daily interruption of sedation(midazolam and fentanyl ); Drug: Light sedation(midazolam and fentanyl )

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Experimental: 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 .	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
Experimental: 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.	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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Delirium; Critical Illness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam
• Other Study ID Numbers: West ChinaH Sedation