Magnesium Sulphate and Sevoflurane Induced Emergence Agitation in Children

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.

Conditions

• Emergence Delirium
• Postopertive Delirium
• Emergence Agitation in Children

Interventions

DRUG

Magnesium Sulfate

Magnesium sulphate (MgSO4) 10% solution is going to be used, an initial MgSO4 bolus dose 30mg/kg (i.e. 0.3mL/kg) will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous infusion of 10 mg/kg/hr (i.e. 0.1 ml/kg/h). Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane

DRUG

normal saline

normal saline (NaCl 9%) is going to be used, an initial normal saline bolus dose 0.3ml/kg will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous normal saline infusion of 0.1 ml/kg/h. Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane

Sponsors & Collaborators

• anesthesia department

  collaborator AMBIG

• faculty of medicine

  collaborator AMBIG

• Cairo University

  lead OTHER

Principal Investigators

• Mohamed Abdulatif, Anesthesia Professor · Anesthesia department-Faculty of medicine-Cairo University

Study Design

Allocation

RANDOMIZED

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-02-28

Completion

2013-02-28

Countries

• Egypt

Study Locations