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

Primary Purpose

Agitation, Pediatric Disorder

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
0.9%normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation focused on measuring sevoflurane, pediatric, lower abdominal surgery, caudal, magnesium sulfate, Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Agitation States as Acute Reaction to Exceptional Stress

Eligibility Criteria

1 Year - 6 Years (Child)MaleDoes not accept 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).

Sites / Locations

  • Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

magnesium sulfate

o.9%normal saline

Arm 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.

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

Outcomes

Primary Outcome Measures

measure of postoperative pediatric anesthesia emergence delirium PAED score
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

measure of postoperative sedation score.
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.

Full Information

First Posted
June 3, 2014
Last Updated
June 13, 2014
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02164773
Brief Title
Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.
Official Title
Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Pediatric Disorder
Keywords
sevoflurane, pediatric, lower abdominal surgery, caudal, magnesium sulfate, Magnesium Sulfate Causing Adverse Effects in Therapeutic Use, Agitation States as Acute Reaction to Exceptional Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magnesium sulfate
Arm Type
Active Comparator
Arm 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.
Arm Title
o.9%normal saline
Arm Type
Placebo Comparator
Arm Description
0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
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
Intervention Name(s)
0.9%normal saline
Intervention Description
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 Measure Information:
Title
measure of postoperative pediatric anesthesia emergence delirium PAED score
Description
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.
Time Frame
first 30 minutes postoperative
Secondary Outcome Measure Information:
Title
measure of postoperative sedation score.
Description
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.
Time Frame
the first 30 minutes postoperatively
Other Pre-specified Outcome Measures:
Title
postoperative rescue propofol intravenous 1mg/kg in cases if agitation
Description
if emergence agitation occur giving of 1mg/kg of intravenous propofol as rescue medication
Time Frame
first 30 minutes postoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ashraf elsayed elagamy, MD anesthesia
Phone
00966546683234
Email
elagamy_ashraf@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
wael yahir
Email
waelibrahimtahir@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa Elkateb, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashraf Elagamy, MD anesthesia
Email
elagamy_ashraf@yahoo.com
First Name & Middle Initial & Last Name & Degree
wael tahir, MDanesthesia
Email
waelibrahimtahir@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ashraf elagamy, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19076110
Citation
Saadawy I, Boker A, Elshahawy MA, Almazrooa A, Melibary S, Abdellatif AA, Afifi W. Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatrics. Acta Anaesthesiol Scand. 2009 Feb;53(2):251-6. doi: 10.1111/j.1399-6576.2008.01818.x. Epub 2008 Dec 6.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/20833531
Description
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Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.

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