ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02078583
Recruitment Status : Unknown
Verified July 2014 by Peking University People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Fentanyl Drug: Remifentanil Drug: Normal saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : July 2014
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Fentanyl

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



Primary Outcome Measures :
  1. The incidence and duration of delirium in patients with different regimens [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
  2. Ventilator-free days [ Time Frame: an expected average of 7 days ]
  3. Mean days of mechanical ventilation [ Time Frame: an expected average of 7 days ]
  4. Length of ICU stay [ Time Frame: an expected average of 7 days ]
  5. Index of anesthesia depth monitoring [ Time Frame: From admission to ICU to weaning,about 7 days ]
    Analgesic level、sedation level、brain function、 blood perfusion for peripheral and brain circulation、sleep stages and variation of blood volume

  6. Infusion velocity and total dose of sedative drugs in different groups [ Time Frame: From admission to ICU to extubation or drug withdrawal,about 7 days ]
  7. Plasma melatonin level [ Time Frame: Every 6 hours during the next ICU day ]
  8. Total rescue dose of midazolam [ Time Frame: Seven days after giving midazolam to patient ]
  9. Variations of HR、RR、BP、SpO2 [ Time Frame: an expected average of 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078583


Contacts
Contact: Dan Liu, Resident physician +8613811365572 fancyjuice@126.com

Sponsors and Collaborators
Peking University People's Hospital

Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02078583     History of Changes
Other Study ID Numbers: PEKING SEDATION
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Fentanyl
Remifentanil
Midazolam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action