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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: The Efficacy and Safety of Intranasal Dexmedetomidine

Treatments: Drug: Dexmedetomidine 2μg.kg-1,1 milliliter; Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter; Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl; Drug: Normal saline,1 milliliter; Drug: Anesthesia induction, 8% sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02222636

Sedation wei

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 6 months to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Group 1,Normal saline,1 milliliter

Placebo Comparator group

Description:

Patients will be assigned to receive intranasal normal saline 1 milliliter

Treatment:

Drug: Normal saline,1 milliliter

Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl

Drug: Anesthesia induction, 8% sevoflurane

Group 2,dexmedetomidine 1μg.kg-1,1 milliliter

Experimental group

Description:

Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter

Treatment:

Drug: Dexmedetomidine 1 μg.kg-1,1 milliliter

Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl

Drug: Anesthesia induction, 8% sevoflurane

Group 3,dexmedetomidine 2μg.kg-1,1 milliliter

Experimental group

Description:

Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter

Treatment:

Drug: Dexmedetomidine 2μg.kg-1,1 milliliter

Drug: Anesthesia maintenance, 2%~3% sevoflurane,fentanyl

Drug: Anesthesia induction, 8% sevoflurane