Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579937
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy andor Adenoidectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy andor Adenoidectomy a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo a look-alike substance that contains no drug It will also learn about the effect of esketamine in emergence delirium The main questions are
Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo Dose esketamine lower the incidence of emergence delirium compared to placebo Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium
Participants will
Receive intravenous esketamine or placebo a look-alike substance that contains no drug during anesthesia induction Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1 7 and 30
Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo Dose esketamine lower the incidence of emergence delirium compared to placebo Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium
Participants will
Receive intravenous esketamine or placebo a look-alike substance that contains no drug during anesthesia induction Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1 7 and 30
Detailed Description:
Approximately half of children who undergo general anesthesia experience emergence delirium ED and postoperative negative behavioral changes PNBC There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation
Esketamine has sedative analgesic and anti-traumatic stress effects Based on literature analysis and preliminary trials this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children
This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo a look-alike substance that contains no drug to provide a reference for optimizing clinical anesthesia medication regimens
Esketamine has sedative analgesic and anti-traumatic stress effects Based on literature analysis and preliminary trials this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children
This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo a look-alike substance that contains no drug to provide a reference for optimizing clinical anesthesia medication regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None