Application of Different Modes of Esketamine Administration in Pediatric Day Circumcision

NCT ID: NCT05811221

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-02
• Study Completion Date: 2023-06-01

Brief 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.

Detailed 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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

single group

give esketamine 0.75 mg/kg at the time of induction

Group Type: ACTIVE_COMPARATOR

Esketamine of single injection

Intervention Type: DRUG

Single group: give esketamine 0.75 mg/kg at the time of induction

intermittent group

give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again

Group Type: EXPERIMENTAL

Esketamine of Intermittent injection

Intervention Type: DRUG

Intermittent group: give esketamine 0.5mg/kg during anesthesia induction, and during the measuring ring esketamine 0.25mg/kg was given again

Interventions

Esketamine of single injection

Single group: give esketamine 0.75 mg/kg at the time of induction

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

A single injection of esketamine at the time of anesthesia induction; A Intermittent injection of esketamine at the time of anesthesia induction

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Wang wanxia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2023-YKL01-（ke11）

Identifier Type: -

Identifier Source: org_study_id