Magnesium Sulphate and Sevoflurane Induced Emergence Agitation in Children
Status:
Unknown status
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
Rationale:
Pediatric Adenotonsillectomy is a common procedure of brief performed on a day-case basis, in
which rapid recovery with safe airway after extubation is crucial. Sevoflurane is considered
the inhaled anesthetic of choice in such procedures, however it has been reported that
emergence agitation (EA) is a frequent complication in 30-80% of children receiving
sevoflurane general anesthesia. The possible effect of magnesium sulphate on decreasing the
incidence of EA in children was not adequately investigated.
Objective:
To assess the possible effects of intraoperative intravenous magnesium sulphate (MgSO4)
infusion on the incidence of sevoflurane-induced EA in children undergoing
adenotonsillectomy.
Study population and sample size:
Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy under
sevoflurane general anesthesia. 64 patients (32/group) is required to detect a significance
difference of 40% in the incidence of agitation between two groups, with a power of 80% and
alpha error of 5%.
Study design:
A double blind, randomized, placebo controlled study.
Method:
In the placebo group, a normal saline bolus dose 0.3ml/kg will be iv infused followed by a
continuous infusion of 0.1 ml/kg/h. In the MgSO4 group, a MgSO4 bolus dose 0.3mL/kg will be
iv infused followed by a continuous infusion of 0.1 ml/kg/h. infusion terminated by the end
of surgery. Post operative emergence agitation will be assessed by using the Pediatric
Anesthesia Emergence Delirium scale.
Possible risks:
Drug side effects such as facial warmth, flushing, dry mouth, and malaise.
Outcome parameters:
The primary outcome: incidence of sevoflurane-induced EA measured using the Pediatric
Anesthesia Emergence Delirium (PEAD). Secondary outcome: postoperative pain and rescue
analgesic requirements, perioperative hemodynamics, durations of recovery, postoperative
complications
Statistical analysis plan:
Student's t-test or Mann Whitney-U and Chi square or Fisher's exact tests will be used as
appropriate. The possible relationship between EA and pain scores will be evaluated with the
use of Spearman's rank correlation coefficient
Time plan:
6-9 months.