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

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02164773

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Aug 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

measure of postoperative pediatric anesthesia emergence delirium PAED score [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

measure of postoperative sedation score. [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

postoperative rescue propofol intravenous 1mg/kg in cases if agitation [first 30 minutes postoperative]
if emergence agitation occur giving of 1mg/kg of intravenous propofol as rescue medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 6 Years

Sexes Eligible for Study:

Male

Accepts 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.