The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Agitation,Psychomotor

Treatments: Drug: Magnesium Sulfate; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03208452

B1605/346-002

Details and patient eligibility

About

This study designed to evaluate the correlation between the effect of intraoperative magnesium sulfate infusion and the incidence of emergence agitation after pediatric ophthalmic surgery

Full description

Emergence agitation (EA) is a frequent postoperative complication in pediatric patients after general anesthesia. There are several suggested causes of EA and pain has been considered one of them. Magnesium is an N-methyl-D-aspartate (NMDA) receptor antagonist and increasingly used as an analgesic-adjuvant. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the incidence of EA in pediatric patients who undergo ophthalmic outpatient surgery.

Enrollment: 92 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years

Exclusion criteria

• ASA class ≥ III
• imbalance of electrolyte
• myocardial damage or conduction abnormality on ECG
• myasthenia gravis or any other neuromuscular disease
• impaired renal function
• denial to participate in study or not be able to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups, including a placebo group

Normal saline(NS) group

Placebo Comparator group

Description:

loading 50mL of normal saline during 10minutes before starting of surgery, after starting of surgery, continuous infusion of normal saline as placebo by 0.15mg/kg/h until the end of surgery

Treatment:

Drug: Normal saline

Magnesium group

Active Comparator group

Description:

loading dose of 50mg/kg magnesium sulfate during 10minutes before starting of surgery, during the surgery, continuous infusion of magnesium sulfate by 15mg/kg/h

Treatment:

Drug: Magnesium Sulfate