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

Agitation Clinical Trial

Official title:

Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164773
• Other study ID #: use of magnesium sulfate
• Status: Recruiting
• Phase: Phase 4
• First received: June 3, 2014
• Last updated: June 13, 2014
• Start date: October 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2014
• Source: Ain Shams University
• Contact: ashraf elsayed elagamy, MD anesthesia
• Phone: 00966546683234
• Email: elagamy_ashraf[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 6 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Agitation
• Pediatric Disorder
• Psychomotor Agitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative rescue propofol intravenous 1mg/kg in cases if agitation	if emergence agitation occur giving of 1mg/kg of intravenous propofol as rescue medication	first 30 minutes postoperative	Yes
Primary	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.	first 30 minutes postoperative	Yes
Secondary	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.	the first 30 minutes postoperatively	Yes

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