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

A

Ain Shams University

Status and phase

Unknown
Phase 4

Conditions

Agitation
Pediatric Disorder

Treatments

Drug: 0.9%normal saline
Drug: Magnesium Sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT02164773
use of magnesium sulfate

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

Male

Ages

1 to 6 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

magnesium sulfate
Active Comparator group
Description:
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.
Treatment:
Drug: Magnesium Sulfate
o.9%normal saline
Placebo Comparator group
Description:
0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block.
Treatment:
Drug: 0.9%normal saline

Trial contacts and locations

1

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Central trial contact

wael yahir; ashraf elsayed elagamy, MD anesthesia

Data sourced from clinicaltrials.gov

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