Magnesium Sulphate and Sevoflurane Induced Emergence Agitation in Children

Phase 4

• Conditions: Emergence Delirium; Postopertive Delirium; Emergence Agitation in Children
• Interventions: Drug: normal saline; Drug: Magnesium Sulfate

• Registration Number: NCT01743144
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-18
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-13
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Children 4-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included in the study.

Read More

Exclusion Criteria

• The study will exclude children with behavioral changes, physical developmental delay and children on treatment with sedative or anticonvulsant. Also children with pre-existing renal disease or cardiovascular diseases will be excluded.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	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
Magnesium sulphate	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

Primary Outcome Measures

Name	Time	Method
change from baseline of sevoflurane induced emergence agitation(EA) at 2 hours postoperative by using Pediatric Anesthesia Emergence Delirium (PEAD) score	on arrival to post anesthesia care unit (PACU) as baseline , then every 10 minutes up to 2 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
postoperative pain which is going to be assessed by the well established behavior pain scale "Children's Hospital Eastern Ontario Scale" (CHEOPS)	on arrival to post anesthesia care unit (PACU) as baseline , then every 10 minutes up to 2 hours postoperatively

Trial Locations

Locations (1)

Anesthesia department - Faculty of medicine- Cairo University; 🇪🇬 Cairo, Egypt