Status:
UNKNOWN
Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
Lead Sponsor:
Henan Provincial People's Hospital
Conditions:
Anxiety-depression
Eligibility:
All Genders
8-18 years
Phase:
EARLY_PHASE1
Brief Summary
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vi...
Eligibility Criteria
Inclusion
- 8 years ≤ age ≤17 years;
- Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
- ASA grade I-II
Exclusion
- Patients expected to be admitted to ICU after surgery;
- Patients who need to return to the ward with tracheal intubation after surgery;
- Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
- Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
- Patients with congenital heart disease and severe developmental delay;
- Patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) Patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg); (d) Untreated or undertreated hyperthyroidism;
- Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06073015
Start Date
October 10 2023
End Date
February 10 2025
Last Update
October 10 2023
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