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

NCT ID: NCT02078583

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31

Brief Summary

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Remifentanil，midazolam

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

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

Fentanyl，midazolam

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

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

Normal saline

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Interventions

Fentanyl

Intervention Type: DRUG

Remifentanil

Intervention Type: DRUG

Normal saline

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dan Liu, Resident physician

Role: CONTACT

fancyjuice@126.com

+8613811365572

Other Identifiers

PEKING SEDATION

Identifier Type: -

Identifier Source: org_study_id