Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 5:38 AM
Study NCT ID:
NCT07082894
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Oral Magnesium on Emergence Agitation
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
The Effect of Preoperative Oral Magnesium on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Double Blind Randomized Placebo Controlled Study
Status:
RECRUITING
Status Verified Date:
2025-07
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:
This prospective randomized controlled study will be conducted to evaluate the effects of preoperative oral magnesium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Detailed Description:
Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness. Regarding its use as a preventive measure against emergence agitation in children, only intraoperative intravenous route was studied and the results of previous reports were inconsistent. Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.
In this novel study, the investigators will use magnesium via oral route before surgery as they hypothesize that the pre-emptive administration of the drug may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may explain its prophylactic benefit against emergence agitation.
In this novel study, the investigators will use magnesium via oral route before surgery as they hypothesize that the pre-emptive administration of the drug may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may explain its prophylactic benefit against emergence agitation.
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?: