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The study of esketamin in anesthesia and comfort health care: the effect of esketamin on preoperative anxiety in children

The study of esketamin in anesthesia and comfort health care: the effect of esketamin on preoperative anxiety in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067458
Enrollment
Unknown
Registered
2023-01-09
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative seperation anxiety in children

Interventions

esketamine oral:oral administration of esketamine before general anesthesia anesthesia
esketamine intranasal:intralnasal esketamine
midazolam-esketamine:oral midazolam, intranasal esketamine
oral midazolam-esketamine:oral midazolam & esketamine
oral esketamin ED95:oral esketamin
intralnasal esketamine ED95:intralnasal esketamine

Sponsors

The anesthesia & comfort health center, Xi'an International Medical Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1) Children undergoing surgery under general anesthesia; 2) Age 1-6 years-old, gender is not limited; 3) ASA I-II; 4) The legal guardians of the children are willing to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Malnourished or obese children; 2) Cushing's syndrome, pituitary tumor, adrenal tumor and other endocrine system diseases; 3) Suffering from severe respiratory disease (obstructive sleep apnea syndrome, acute respiratory infection, uncontrolled asthma, active massive hemoptysis, pulmonary hypertension, etc.); 4) Any congenital heart disease, acute heart failure, atrioventricular block, severe arrhythmia; 5) Infectious heart diseases such as myocarditis or endocarditis; sepsis; pneumonia. 6) Those who suffer from mental system diseases (autism, ADHD, schizophrenia), abnormal brain development and cognitive dysfunction; 7) Anemia or thrombocytopenia: HbULN+3s and/or APTT>ULN+10s); 9) Abnormal liver function: AST and/or ALT=2.5×ULN, TBIL=1.5×ULN; 10) Abnormal renal function: urea or blood urea nitrogen = 1.5×ULN, serum creatinine is greater than the upper limit of normal; 11) Patients with unsatisfactory control of blood sugar (random blood sugar =11.1mmol/L during the screening period); 12) Those who are allergic to or have contraindications to benzodiazepines, opioids, etomidate, propofol, ketamine and other drugs and their components; 13) Patients who are judged to have difficulty in airway management (modified Markov score is grade IV); 14) Participated in any clinical drug trial as a subject within the past 3 months and used the trial drug; 15) within 2 weeks of taking monoamine oxidase inhibitors; 16) Taking sedative drugs, antiemetic drugs, motion sickness drugs, and antipruritic drugs within 48 hours before surgery; 17) Other factors that may interfere with the experimental results.

Design outcomes

Primary

MeasureTime frame
Separation Anxiety Score from Parents(PSAS);

Secondary

MeasureTime frame
sedation success rate;Induction Compliance Checklist (ICC) Scale;Parental Separation Anxiety Scale;anaesthesiologist satisfaction with induction based on the visual analogue scale;emergence agitation scale score;extubation time;PACU staying time;

Countries

China

Contacts

Public ContactSiyuan Li

Xi'an International Medical Center Hospital

foxlsy@163.com18681875961

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026