Effect of Preoperative Oral Magnesium on Emergence Agitation

Tanta University

Status: Enrolling

Conditions: Adenotonsillectomy; Emergence Agitation; Magnesium

Treatments: Other: Placebo control; Drug: Magnesium

Study type: Interventional

Funder types: Other

Identifiers

NCT07082894

36264PR1217/5/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both gender
• 4 to 7 years age
• American Society of Anesthesiologists (ASA) Physical Status I or II
• Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia

Exclusion criteria

• Parents declined to participate in the trial
• Children with behavioral changes; neurological or psychiatric diseases
• Physical or developmental delay
• Sedative or anticonvulsant medication
• Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
• Allergy to magnesium

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Magnesium group

Experimental group

Description:

cases will receive preoperative oral magnesium dose of 120 mg at one hour before surgery

Treatment:

Drug: Magnesium

Control group

Placebo Comparator group

Description:

cases will receive oral lemon juice at one hour before surgery.

Treatment:

Other: Placebo control