The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children

The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children : A Single Center ,Randomized ,Double-blinded, Controlled Study.

The purpose of this study is to explore the optimal protocol for dexmedetomidine used in children during perioperative period.

Study Overview

• Status: Unknown
• Conditions: The Efficacy and Safety of Intranasal Dexmedetomidine
• Intervention / Treatment: Drug: Normal saline,1 milliliter; Drug: Anesthesia induction, 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl; Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter; Drug: Dexmedetomidine 2μg.kg-1,1 milliliter

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Elective cleft lip and cleft palate repair surgery
• American Society of Anesthesiologists class I
• Aged between 6 months and 7 years old

Exclusion Criteria:

• Suspected or confirmed difficult airway
• History of upper respiratory tract infection with 1 month
• Combined with congenital heart disease
• Allergic to investigational products or with other contraindication
• Growth retardation or dysgnosia
• Central nervous system disease
• Serious infection
• Serious heart,brain,liver,kidney, pulmonary, and endocrine disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1,Normal saline,1 milliliter; Patients will be assigned to receive intranasal normal saline 1 milliliter	Drug: Normal saline,1 milliliter; Normal saline,1 milliliter, 20 minutes before anaesthetic induction; Drug: Anesthesia induction, 8% sevoflurane; Inhalation induction with 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl; 2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
Experimental: Group 2,dexmedetomidine 1μg.kg-1,1 milliliter; Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter	Drug: Anesthesia induction, 8% sevoflurane; Inhalation induction with 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl; 2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion; Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter; Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Experimental: Group 3,dexmedetomidine 2μg.kg-1,1 milliliter; Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter	Drug: Anesthesia induction, 8% sevoflurane; Inhalation induction with 8% sevoflurane; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl; 2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion; Drug: Dexmedetomidine 2μg.kg-1,1 milliliter; Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sedation-Agitation Scale	The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
The pediatric anesthesia emergence delirium scale	The moment of entering operating room,and from discontinuation of inhalational anesthetics to the moment of patient's consciousness recovery,an expected average of 1 hour
Anesthesia induction time	From beginning of inhalating anesthetics to the moment of intubation
Anesthesia maintenance time	From the moment of intubation to the discontinuation of inhalational anesthestics
Recovery time	From discontinuation of inhalational anesthestics to the moment of patient's consciousness recovery, an expected average of 1 hour
Change from baseline in blood pressure during anesthesia	The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Change from baseline in heart rate during anesthesia	The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Change from baseline in respiratory rate during anesthesia	The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction

Secondary Outcome Measures

Outcome Measure	Time Frame
The alveolar concentration of inhalational anesthetics	the moment of anesthesia induction,the moment of intubation,before cutting skin

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 14, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

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

More Information

Terms related to this study

• Keywords: The efficacy and safety of intranasal dexmedetomidine
• 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; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Anesthetics; Fentanyl; Dexmedetomidine; Sevoflurane
• Other Study ID Numbers: Sedation wei