Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

Pain Clinical Trial

Official title:

Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05811221
• Other study ID #: 2023-YKL01-(ke11)
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain

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