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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05811221
Other study ID # 2023-YKL01-(ke11)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2, 2023
Est. completion date June 1, 2023

Study information

Verified date March 2023
Source Yangzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To explore the application of different administration modes of esketamine in pediatric day circumcision, in order to find an anesthesia scheme more suitable for day pediatric circumcision.


Description:

The current clinical study believes that esketamine is suitable for pediatric anesthesia because of its advantages of light respiratory depression, low secretions, low incidence of psychomotor reactions and fast recovery of anesthesia, but there are few related studies on its administration mode and timing in clinical application, this study aims to explore the application of different administration methods of esketamine in pediatric day circumcision, and find an anesthesia scheme more suitable for day circumcision, in order to provide new ideas for anesthesia for pediatric day circumcision.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date June 1, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender Male
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) class I and II children - Age 5-12 years - Foreskin cerclage is proposed - No history of upper respiratory tract infection in the past two weeks - Obtain the consent of the child's family Exclusion Criteria: - Hepatic and renal insufficiency, coagulation dysfunction - Those who are allergic to esketamine - History of cognitive impairment - epilepsy - other psychiatric and neurological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Esketamine of single injection
Single group: give esketamine 0.75 mg/kg at the time of induction
Esketamine of Intermittent injection
Intermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yangzhou University

Outcome

Type Measure Description Time frame Safety issue
Primary One-time success rate of anesthesia No movement during anesthesia During surgery
Secondary Systolic blood pressure Systolic blood pressure During surgery
Secondary Diastolic blood pressure Diastolic blood pressure During surgery
Secondary Heart rate Heart rate During surgery
Secondary intraoperative propofol dosage, esketamine dosage intraoperative propofol dosage, esketamine dosage During surgery
Secondary Duration of surgery Duration of surgery During surgery
Secondary Time to open eyes Time to open eyes During surgery
Secondary Time to talk Time to talk During surgery
Secondary VAS(visual analogue scale) score A score to assess pain, use a swimming ruler about 10 cm long, marked with 10 scales on one side, with "0" and "10" ends at each end, 0 points means no pain, and 10 points represent the most severe pain that is unbearable. 12 hours after the end of surgery
Secondary Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania) Incidence of adverse effects (hypotension, hypertension, respiratory depression, postoperative pain, diplopia, mania) 12 hours after the end of surgery
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