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

Xijing Hospital60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

The Efficacy and Safety of Intranasal Dexmedetomidine

Interventions

Normal saline,1 milliliterDRUG

Normal saline,1 milliliter, 20 minutes before anaesthetic induction

Dexmedetomidine 1 μg.kg-1,1 milliliterDRUG

Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction

Dexmedetomidine 2μg.kg-1,1 milliliterDRUG

Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sedation-Agitation Scale

Time frame: 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

Time frame: 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

Time frame: From beginning of inhalating anesthetics to the moment of intubation

Anesthesia maintenance time

Time frame: From the moment of intubation to the discontinuation of inhalational anesthestics

Recovery time

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: The moment of entering operating room,20 minutes before anesthesia induction,10 minutes before anesthesia inducion,the moment of anesthesia induction

Secondary Outcomes

Data from ClinicalTrials.gov

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