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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02164773
Recruitment Status : Unknown
Verified June 2014 by Ashraf Elsayed Elagamy, Ain Shams University.
Recruitment status was:  Recruiting
First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Ashraf Elsayed Elagamy, 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.

Condition or disease Intervention/treatment Phase
Agitation Pediatric Disorder Drug: Magnesium Sulfate Drug: 0.9%normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children
Study Start Date : October 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.

Placebo Comparator: o.9%normal saline
0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block.
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.




Primary Outcome Measures :
  1. measure of postoperative pediatric anesthesia emergence delirium PAED score [ Time Frame: 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 :
  1. measure of postoperative sedation score. [ Time Frame: 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.


Other Outcome Measures:
  1. postoperative rescue propofol intravenous 1mg/kg in cases if agitation [ Time Frame: first 30 minutes postoperative ]
    if emergence agitation occur giving of 1mg/kg of intravenous propofol as rescue medication



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164773


Contacts
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Contact: ashraf elsayed elagamy, MD anesthesia 00966546683234 elagamy_ashraf@yahoo.com
Contact: wael yahir waelibrahimtahir@hotmail.com

Locations
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Egypt
Ain Shams University Recruiting
Cairo, Egypt, 11566
Contact: Ashraf Elagamy, MD anesthesia       elagamy_ashraf@yahoo.com   
Contact: wael tahir, MDanesthesia       waelibrahimtahir@hotmail.com   
Principal Investigator: Ashraf elagamy, MD         
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Alaa Elkateb, MD Ain Shams University

Additional Information:
Publications:
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Responsible Party: Ashraf Elsayed Elagamy, ashraf elagamy, Ain Shams University
ClinicalTrials.gov Identifier: NCT02164773    
Other Study ID Numbers: use of magnesium sulfate
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014
Keywords provided by Ashraf Elsayed Elagamy, Ain Shams University:
sevoflurane
pediatric
lower abdominal surgery
caudal
magnesium sulfate
Magnesium Sulfate Causing Adverse Effects in Therapeutic Use
Agitation States as Acute Reaction to Exceptional Stress
Additional relevant MeSH terms:
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Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Magnesium Sulfate
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents