Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.
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|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
|Condition or disease||Intervention/treatment||Phase|
|Agitation Pediatric Disorder||Drug: Magnesium Sulfate Drug: 0.9%normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- 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.
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164773
|Contact: ashraf elsayed elagamy, MD email@example.com|
|Contact: wael firstname.lastname@example.org|
|Study Director:||Alaa Elkateb, MD||Ain Shams University|