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

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.

Study Overview

• Status: Unknown
• Conditions: Delirium
• Intervention / Treatment: Drug: Fentanyl; Drug: Normal saline; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Remifentanil
EXPERIMENTAL: 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	Drug: Fentanyl
PLACEBO_COMPARATOR: 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	Drug: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence and duration of delirium in patients with different regimens	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume	From admission to ICU to weaning,about 7 days
Infusion velocity and total dose of sedative drugs in different groups		From admission to ICU to extubation or drug withdrawal,about 7 days
Plasma melatonin level		Every 6 hours during the next ICU day
Total rescue dose of midazolam		Seven days after giving midazolam to patient
Variations of HR、RR、BP、SpO2		an expected average of 7 days

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Fentanyl
• Other Study ID Numbers: PEKING SEDATION