Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients
Intranasal Dexmedetomidine or Oral Midazolam Alone Versus Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Minor Surgery
1 other identifier
interventional
138
1 country
1
Brief Summary
Children tend to anxiety and even fear before survey. And this kind of anxiety will not result in the forced induction of anesthesia, but also may increase the incidence of postoperative agitation in children, even lead to postoperative behavior changes.Currently,Oral midazolam or intranasal dexmedetomidine alone is commonly used as a preoperative regimen, but the clinical effects of each single-use are not satisfactory. In the investigators' study，the researchers conducted the current study to investigate whether dexmedetomidine combined with midazolam can increase the rate of satisfactory anesthesia induction in pediatric patients and achieve better sedative effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 anxiety
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Start
First participant enrolled
October 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 5, 2019
November 1, 2019
11 months
October 17, 2019
November 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The degree of cooperation during inhalation anesthesia induction
Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction
During inhalation anesthesia induction
Secondary Outcomes (7)
Anxiety before induction of anesthesia
Before preoperative medication
The level of sedation
Each 10 minutes during the preoperative period
The onset time of satisfactory sedation
During the preoperative period
Parental separation anxiety scale
During the preoperative period
Recovery times
Within up to 30 minutes after child's first eye opening in the postoperative period
- +2 more secondary outcomes
Study Arms (3)
Midazolam
PLACEBO COMPARATORPatients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
Dexmedetomidine
EXPERIMENTALPatients were assigned to receive intranasal dexmedetomidine 2ug/kg approximately 30-40 minutes before surgery using a computer-generated random number table.
Midazolam and Dexmedetomidine
EXPERIMENTALPatients were assigned to receive intranasal dexmedetomidine 1ug.kg-1 and oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
Interventions
oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
intranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.
oral midazolam 0.5mg.kg-1 and intranasal dexmedetomidine 1ug.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.
Eligibility Criteria
You may qualify if:
- with American Society of Anesthesiologists (ASA) physical status I or II；
- aged 2-6 years；
- children with weight for age within the normal range
- were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.
You may not qualify if:
- Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
- contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or midazolam;
- with any nasal pathology,organ dysfunction;
- recently respiratory infection, mental disorder;
- other reasons that researchers hold it is not appropriate to participate in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huacheng Liu
Second Affiliated Hospital of Wenzhou Medical University
- PRINCIPAL INVESTIGATOR
Yuhang Cai
Second Affiliated Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 22, 2019
Study Start
October 25, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
November 5, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share