The Effect of Analgesia Based Sedation Protocol on Brain Function of Critical Care Patients

Peking University

Status and phase: Unknown; Phase 4

Conditions: Delirium

Treatments: Drug: Remifentanil; Drug: Fentanyl; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02078583

PEKING SEDATION

Details and patient eligibility

About

Benzodiazepines is a commonly uesd sedative medication,there are many reports that Benzodiazepines is associated with delirium ,but using of analgesia reduces benzodiazepines requirements .The purpose of this study is to determine whether analgesia based sedation protocol reduces the incident of delirium.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signing a consent form
• postoperative patient
• Requirement for mechanical ventilation and anticipate time of mechanical ventilation more than 24 hours
• Requirement for sedation
• Age more than 18 and less than 85 years old

Exclusion criteria

• Unstable blood circulation
• Heart rate less than 50 beats per minute
• II ° ～ III ° atrioventricular conduct block
• Intracranial lesions 、neurosurgical intervention and mental disability inability to cooperate;
• Receipt of antipsychotics 、hypnotic drugs before surgery ;
• Alcohol abuse;
• Liver failure class Child-Pugh C;
• Acute Respiratory Distress Syndrome;
• Acute or chronic renal failure;
• Other severe diseases ,septic shock;
• Receipt of neuromuscular blocking drug;
• Pregnancy and nursing woman;
• Allergy to investigational drug or other contraindication.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 3 patient groups, including a placebo group

Remifentanil，midazolam

Experimental group

Description:

Remifentanil 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02\~0.1mg/kg/h continuous intravenous pump for 7days or extubation

Treatment:

Drug: Remifentanil

Fentanyl，midazolam

Experimental group

Description:

Fentanyl 1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02\~0.1mg/kg/h continuous intravenous pump for 7days or extubation

Treatment:

Drug: Fentanyl

Normal saline

Placebo Comparator group

Description:

Normal saline1µg/kg/hr intravenous pump and Midazolam loading dose 0.05mg/kg followed by 0.02\~0.1mg/kg/h continuous intravenous pump for 7days or extubation

Treatment:

Drug: Normal saline