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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Agitation Pediatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

use of 50mg magnesium sulfate in caudal analgesia added to 1ml/kg of 0.25% of bupivacaine in children undergoing lower abdominal surgery for prevention of postoperative emergence agitation.

o.9%normal saline

0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block.

Group Type PLACEBO_COMPARATOR

0.9%normal saline

Intervention Type DRUG

use of 1ml of 0.9%normal saline added to 1ml/kg of 0.25% of bupivacaine in the caudal block as placebo to compare with active comparator.

Interventions

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Magnesium Sulfate

use of 50mg magnesium sulfate in caudal analgesia added to 1ml/kg of 0.25% of bupivacaine in children undergoing lower abdominal surgery for prevention of postoperative emergence agitation.

Intervention Type DRUG

0.9%normal saline

use of 1ml of 0.9%normal saline added to 1ml/kg of 0.25% of bupivacaine in the caudal block as placebo to compare with active comparator.

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No