Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients

Phase

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04135014

SAHoWMU-CR2019-03-111

Ages 2-6
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 timeshorter than 30 minutes.

Exclusion

Exclusion Criteria:

Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
contraindication to preoperative sedation or had a known allergy or hypersensitivereaction 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 thistrial.

Study Design

October 25, 2019

October 31, 2020

Study Description

A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety Scale(mYPAS) after obtaining consent. And corresponding study medication is administered about 30-40 minutes before the anesthesia induction.Vital signs were measured every 5 min after study medication administration.The sedation scores of the children were recorded with University of Michigan Sedation Scale (UMSS) every 10 minutes.The onset time of satisfactory sedation and parental separation anxiety scale was noted.Then recorded the degree of cooperation during inhalation anesthesia induction and recovery times.Moreover, recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

Connect with a study center

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
China
Active - Recruiting

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