The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children
NCT ID: NCT02222636
Last Updated: 2014-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.
NCT07180095
Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children
NCT02261675
Comparison of Two Doses of Intranasal Dexmedetomidine as Premedication in Children
NCT01065701
Different Premedication in Pediatric Patients
NCT04266340
The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
NCT02296073
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1,Normal saline,1 milliliter
Patients will be assigned to receive intranasal normal saline 1 milliliter
Normal saline,1 milliliter
Normal saline,1 milliliter, 20 minutes before anaesthetic induction
Anesthesia induction, 8% sevoflurane
Inhalation induction with 8% sevoflurane
Anesthesia maintenance, 2%~3% sevoflurane,fentanyl
2%\~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
Group 2,dexmedetomidine 1μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 1μg.kg-1) 1 milliliter
Dexmedetomidine 1 μg.kg-1,1 milliliter
Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Anesthesia induction, 8% sevoflurane
Inhalation induction with 8% sevoflurane
Anesthesia maintenance, 2%~3% sevoflurane,fentanyl
2%\~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
Group 3,dexmedetomidine 2μg.kg-1,1 milliliter
Patients will be assigned to receive intranasal dexmedetomidine( 2μg.kg-1 )1 milliliter
Dexmedetomidine 2μg.kg-1,1 milliliter
Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Anesthesia induction, 8% sevoflurane
Inhalation induction with 8% sevoflurane
Anesthesia maintenance, 2%~3% sevoflurane,fentanyl
2%\~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Normal saline,1 milliliter
Normal saline,1 milliliter, 20 minutes before anaesthetic induction
Dexmedetomidine 1 μg.kg-1,1 milliliter
Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Dexmedetomidine 2μg.kg-1,1 milliliter
Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
Anesthesia induction, 8% sevoflurane
Inhalation induction with 8% sevoflurane
Anesthesia maintenance, 2%~3% sevoflurane,fentanyl
2%\~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elective cleft lip and cleft palate repair surgery
* American Society of Anesthesiologists class I
* Aged between 6 months and 7 years old
Exclusion Criteria
* 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
6 Months
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xijing Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
wangqiang
department of anesthesijology
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sedation wei
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.