NCT02164773

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

June 3, 2014

Last Update Submit

June 13, 2014

Conditions

AgitationPediatric Disorder

Keywords

sevofluranepediatriclower abdominal surgerycaudalmagnesium sulfateMagnesium Sulfate Causing Adverse Effects in Therapeutic UseAgitation States as Acute Reaction to Exceptional Stress

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • measure of postoperative sedation score.

    the first 30 minutes postoperatively

Other Outcomes (1)

  • postoperative rescue propofol intravenous 1mg/kg in cases if agitation

    first 30 minutes postoperative

Study Arms (2)

magnesium sulfate

ACTIVE COMPARATOR

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

o.9%normal saline

PLACEBO COMPARATOR

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

Drug: 0.9%normal saline

Interventions

Magnesium SulfateDRUG

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.

magnesium sulfate
0.9%normal salineDRUG

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.

o.9%normal saline

Eligibility Criteria

Age1 Year - 6 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • children with developmental delay
  • neurological disorder.
  • psychological disorder
  • difficult airway
  • hyperactive airway disease
  • contraindication to caudal block(sacral abnormality,bleeding disorder).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

RECRUITING

Related 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.

    PMID: 19076110BACKGROUND

Related Links

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Alaa Elkateb, MD

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

ashraf elsayed elagamy, MD anesthesia

CONTACT

00966546683234elagamy_ashraf@yahoo.com

wael yahir

CONTACT

waelibrahimtahir@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ashraf elagamy

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 17, 2014

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

EG(1)