AgitationPhase 4NCT02164773
Addition of Magnesium Sulfate to Caudal to Prevent Postoperative Emergence Agitation.
A Phase 4 study testing Magnesium Sulfate and 0.9%normal saline in people with Agitation and Pediatric Disorder, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years, men only
- Conditions the study is for
- Agitation, Pediatric Disorder
- What is being tested?
- Magnesium Sulfate and 0.9%normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2013to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- children with developmental delay
- neurological disorder.
- psychological disorder
- difficult airway
- hyperactive airway disease
- contraindication to caudal block(sacral abnormality,bleeding disorder).
Trial locations and contacts
1 site in 1 country.
wael yahir contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11566
Ashraf Elagamy, MD anesthesia, elagamy_ashraf@yahoo.com
wael tahir, MDanesthesia, waelibrahimtahir@hotmail.com
About this study
Official title: Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children
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.
Read the 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.
- Conditions
- Agitation, Pediatric Disorder
- Being tested
- Magnesium Sulfate, 0.9%normal saline
- 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
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Magnesium Sulfate |
| o.9%normal saline | Placebo comparator | 0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block. Receives: Drug: 0.9%normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first 30 minutes postoperative
Secondary outcomes (1)
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.
Measured: the first 30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Elsayed Elagamy, Ain Shams University
- Investigators
- Alaa Elkateb, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164773
- Sponsor's protocol ID
- use of magnesium sulfate
- Status last verified
- Jun 2014
- First submitted
- 3 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19076110
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Magnesium Sulfate to Caudal for Prevention of Emergence Agitation in Children
- ClinicalTrials.gov ID
- NCT02164773
- Acronym / sponsor ID
- use of magnesium sulfate
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium sulfate | Active comparator | Drug: Magnesium Sulfatemagnesium 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. |
| o.9%normal saline | Placebo comparator | Drug: 0.9%normal saline0.9% of normal saline added to the conventional 0.25% bupivacaine in caudal block. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- children with developmental delay
- neurological disorder.
- psychological disorder
- difficult airway
- hyperactive airway disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfateuse 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. | Drug | magnesium sulfate |
| 0.9%normal salineuse 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. | Drug | o.9%normal saline |
Primary outcome
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.
1 secondary outcome
measure of postoperative sedation score.
Time frame: the first 30 minutes postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Background: PubMed 19076110Saadawy 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wael yahir contact
Alaa Elkateb, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate and 0.9%normal saline in people with Agitation and Pediatric Disorder, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ashraf elsayed elagamy, MD anesthesia (00966546683234, elagamy_ashraf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of postoperative pediatric anesthesia emergence delirium PAED score (time frame: first 30 minutes postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02164773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.