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

Phase 4

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

• Registration Number: NCT02222636
• Lead Sponsor: Xijing Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Study First Posted: 2014-08-21
• Last Update Posted: 2014-08-21
• Study Start: 2014-09
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter	Dexmedetomidine 1 μg.kg-1,1 milliliter	Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
Group 1,Normal saline,1 milliliter	Anesthesia induction, 8% sevoflurane	Patients will be assigned to receive intranasal normal saline 1 milliliter
Group 1,Normal saline,1 milliliter	Anesthesia maintenance, 2%~3% sevoflurane,fentanyl	Patients will be assigned to receive intranasal normal saline 1 milliliter
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter	Anesthesia induction, 8% sevoflurane	Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter	Anesthesia maintenance, 2%~3% sevoflurane,fentanyl	Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
Group 1,Normal saline,1 milliliter	Normal saline,1 milliliter	Patients will be assigned to receive intranasal normal saline 1 milliliter
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter	Dexmedetomidine 2μg.kg-1,1 milliliter	Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter	Anesthesia induction, 8% sevoflurane	Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter	Anesthesia maintenance, 2%~3% sevoflurane,fentanyl	Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter

Primary Outcome Measures

Name	Time	Method
Sedation-Agitation Scale	The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction
Anesthesia maintenance time	From the moment of intubation to the discontinuation of inhalational anesthestics
Anesthesia induction time	From beginning of inhalating anesthetics to the moment of intubation
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
The alveolar concentration of inhalational anesthetics	the moment of anesthesia induction,the moment of intubation,before cutting skin