Tanta University
Tanta, Gharbia Governorate, 31527, Egypt
NCT Number: NCT07082894
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.
Looking for future studies?
Notify Me4 year–7 year
All sexes
Interventional
Not applicable
Tanta, Gharbia Governorate, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
preoperative oral magnesium dose of 120 mg at one hour before surgery will be given.
preoperative oral lemon juice at one hour before surgery will be given.
Time frame: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour
Time frame: Perioperative
It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 will be considered as 'acceptable' separation
Time frame: Perioperative
Ease of mask acceptance will be graded using the Mask Acceptance Score. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 will be considered 'satisfactory' mask acceptance
Time frame: Up to 1 hour after surgery.
the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at PACU arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl.
Time frame: Up to 1 hour after surgery.
Fentanyl will be given for agitation or pain
Time frame: Up to 1 hour after surgery.
severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale.
Time frame: Up to 2 hours after surgery.
Any episodes of nausea and vomiting will be recorded.
Tanta University
Other
The Effect of Preoperative Oral Magnesium on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Double Blind Randomized Placebo Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07655817
Adenotonsillectomy, Children
Tanta, Gharbia Governorate, Egypt
View Trial DetailsNCT05339308
Magnesium, Skeletal Muscle Contraction Properties
Brno, Czechia
View Trial DetailsNCT05132517
Brain Diseases, Cardiovascular Diseases
Hessisch Oldendorf, Lower Saxony, Germany
View Trial DetailsNCT07338565
Bile Acid Diarrhea, Bile Acid Malabsorption
Aarhus N, Denmark
View Trial Details