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

NCT02078583 | Unknown Phase 4

• 1 other identifier: PEKING SEDATION
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The incidence and duration of delirium in patients with different regimens

  1 day

Secondary Outcomes (9)

• Mortality

  28 days

• Ventilator-free days

  an expected average of 7 days

• Mean days of mechanical ventilation

  an expected average of 7 days

• Length of ICU stay

  an expected average of 7 days

• Index of anesthesia depth monitoring

  From admission to ICU to weaning,about 7 days

Study Arms (3)

Remifentanil，midazolam

EXPERIMENTAL

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

Drug: Remifentanil

Fentanyl，midazolam

EXPERIMENTAL

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

Drug: Fentanyl

Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Fentanyl DRUG

Fentanyl，midazolam

Remifentanil DRUG

Remifentanil，midazolam

Normal saline DRUG

Normal saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Delirium

Interventions

Fentanyl; Remifentanil; Saline Solution

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Dan Liu, Resident physician

CONTACT

+8613811365572; fancyjuice@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 5, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Last Updated: July 16, 2014

Record last verified: 2014-07