Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.

Phase 4

• Conditions: Pediatric Disorder; Agitation
• Interventions: Drug: 0.9%normal saline; Drug: Magnesium Sulfate

• Registration Number: NCT02164773
• Lead Sponsor: Ain Shams University

Brief Summary

Emergence agitation after sevoflurane anesthesia is still a problem needed to be solved.The aim of the study is to delineate the effect of caudal magnesium sulfate in children undergoing lower abdominal surgery to prevent postoperative emergence agitation.

Detailed Description

Emergency agitation is considered one of the postoperative complication after sevoflurane anesthesia.In the enrollment of this study,children undergoing lower abdominal surgery will be enrolled in one of two groups.BM group, receive caudal magnesium sulfate 50 mg beside the conventional bupivacaine in the caudal space in ,B group, addition of 1 ml of normal saline0.9% to bupivacine .Monitoring of the postoperative emergence agitation by different emergence agitation scores with monitoring of sedation score.Detection of expected postoperative complications as nausea and vomiting.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Study First Posted: 2014-06-17
• Last Update Posted: 2014-06-17
• Primary Completion: 2014-07
• Study Completion: 2014-08

Recruitment & Eligibility

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

Inclusion Criteria

• children undergoing lower abdominal surgery for hernia repair/orchiopexy in Ain Shams University ASA physical status I under sevoflurane anesthesia.
• age from 1-6 years.

Exclusion Criteria

• children with developmental delay
• neurological disorder.
• psychological disorder
• difficult airway
• hyperactive airway disease
• contraindication to caudal block(sacral abnormality,bleeding disorder).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
o.9%normal saline	0.9%normal saline	0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block.
magnesium sulfate	Magnesium Sulfate	magnesium sulfate 50mg caudal 1ml(5%) prepared after addition of 9ml of 0.9%normal saline to 1ml of 500mg(50%)of magnesium sulfate to be added to 1ml/kg of 0.25%of bupivacaine in caudal block in children undergoing lower abdominal surgery under sevoflurane anesthesia to prevent emergence agitation.

Primary Outcome Measures

Name	Time	Method
measure of postoperative pediatric anesthesia emergence delirium PAED score	first 30 minutes postoperative	measurement of PAED score every 5 minutes in the first 30 minutes after lower abdominal surgery in children 1-6 year age after sevoflurane anesthesia.

Secondary Outcome Measures

Name	Time	Method
measure of postoperative sedation score.	the first 30 minutes postoperatively	use of sedation score as a measure of postoperative sedation expected after caudal magnesium sulfate every 5 minutes for 30 minutes after end of surgery.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt