Skip to content

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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02164773
Enrollment
70
Registered
2014-06-17
Start date
2013-10-31
Completion date
2014-08-31
Last updated
2014-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGMagnesium 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.

DRUG0.9%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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
MALE
Age
1 Years to 6 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
measure of postoperative pediatric anesthesia emergence delirium PAED scorefirst 30 minutes postoperativemeasurement 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

MeasureTime frameDescription
measure of postoperative sedation score.the first 30 minutes postoperativelyuse 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

MeasureTime frameDescription
postoperative rescue propofol intravenous 1mg/kg in cases if agitationfirst 30 minutes postoperativeif emergence agitation occur giving of 1mg/kg of intravenous propofol as rescue medication

Countries

Egypt

Contacts

Primary Contactashraf elsayed elagamy, MD anesthesia
elagamy_ashraf@yahoo.com00966546683234
Backup Contactwael yahir
waelibrahimtahir@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026