The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

Study Overview

• Status: Unknown
• Conditions: Failed Conscious Sedation During Procedure
• Intervention / Treatment: Drug: Midazolam; Drug: Fentanyl; Other: assessment; Drug: Dexmedetomidine; Drug: Dexmedetomidine; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. written informed consent；
2. pediatric patients admitted to intensive care unit after general anesthesia;
3. expected mechanical ventilation time >6 hours; （4）1 months to 16 years old; -

Exclusion Criteria:

1. congenital heart disease, arrhythmias and heart failure;
2. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
3. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
4. central nervous system disease;
5. spinal analgesia or muscle relaxants is used during PICU;
6. the drug that affects the nerve conduction is used in one month;
7. allergy to the test drug or having other contraindications;
8. participated in other studies 30 days prior to admission of PICU; -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Midazolam; midazolam 3～5μg/kg•min for maintenance of sedation.	Drug: Midazolam; midazolam 3～5μg/kg•min for maintenance of sedation.; Other Names: Liyuexi; Drug: Fentanyl; Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia; Other Names: Fentai; Other: assessment; Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
EXPERIMENTAL: Dexmedetomidine1; Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；	Drug: Fentanyl; Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia; Other Names: Fentai; Other: assessment; Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.; Drug: Dexmedetomidine; Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi; Drug: Dexmedetomidine; Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi; Drug: Dexmedetomidine; Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi
EXPERIMENTAL: Dexmedetomidine2; Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；	Drug: Fentanyl; Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia; Other Names: Fentai; Other: assessment; Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.; Drug: Dexmedetomidine; Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi; Drug: Dexmedetomidine; Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi; Drug: Dexmedetomidine; Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi
EXPERIMENTAL: Dexmedetomiding3; Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；	Drug: Fentanyl; Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia; Other Names: Fentai; Other: assessment; Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.; Drug: Dexmedetomidine; Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi; Drug: Dexmedetomidine; Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi; Drug: Dexmedetomidine; Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； Other Names: Yisi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of time at target sedation score	assess the sedation level every 2 min using Ramsay score	up to 24 hours
the number of patients requiring the sedation remedy	the number of patients requiring the sedation remedy during the mechanical ventilation	up to 24 hours
the dosage of midazolam that need for the sedation remedy	the dosage of midazolam that need for sedation remedy during the mechanical ventilation	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of blood pressure	the change of blood pressure at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.	up to 24 hours.
change of heart rate	the change of heart rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.	up to 24 hours
change of respiratory rate	the change of respiratory rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.	up to 24 hours
change of blood oxygen saturation	the change of blood oxygen saturation at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.	up to 24 hours
extubation time	time from beginning of study drug used to extubation	up to 24 hours
change of hepatic function	change of blood ALT、AST level at baseline and 24 hours after the sedation drug used.	up to 24 hours
change of renal function	change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used.	up to 24 hours
the dosage of sedation and analgesia drug	the total dosage of sedation and analgesia drug during the sedation and analgesia period	up to 24 hours
the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used		up to 24 hours
the dosage of fentanyl in and after 6 hours from study drug used		up to 24 hours

Collaborators and Investigators

• Sponsor: Anhui Provincial Children's Hospital

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (ESTIMATE): November 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: mechanical ventilation; Sedation; Dexmedetomidine; Pediatric intensive care unit
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Dexmedetomidine
• Other Study ID Numbers: PICUDEX2014