Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925283
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2023-06-12
Brief Title:
Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Organization:
Second Affiliated Hospital of Wenzhou Medical University
Study Overview
Official Title:
Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children are prone to anxiety and even fear before surgery and such adverse emotions may not only lead to poor induction of anesthesia but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children There are many ways to relieve pediatric anxiety including preoperative medication games and cartoons Preoperative medication is the most commonly used method to relieve pediatric anxietyThe most commonly used pediatric preoperative sedation drugs are midazolam and esketamineHowever oral midazolam may not produce a sedative effect in 20-40 of patients A good preoperative anxiety-reducing effect was seen in only 60-80 of casesTherefore this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone This will provide a reference for the selection of safe reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care
Detailed Description:
A trained member of the research team obtained a baseline The Modified Yale Preoperative Anxiety ScalemYPAS after obtaining consent And corresponding study medication is administered about 30-40 minutes before the anesthesia inductionVital signs were measured every 5 min after study medication administrationThe sedation scores of the children were recorded with University of Michigan Sedation Scale UMSS every 10 minutesThe onset time of satisfactory sedation and parental separation anxiety scale was notedThen recorded the degree of cooperation during inhalation anesthesia induction and recovery timesMoreover recorded the pediatric anesthesia emergence delirium scale PAED during the recovery period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None