Magnesium SulphateNCT06977425
Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients
A study testing Magnesium sulphate and Dexmedetomidine in people with Magnesium Sulphate and Dexmedetomidine, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to compare the effectiveness of intraoperative magnesium sulfate versus dexmedetomidine infusions on emergence agitation that follows anesthesia using sevoflurane immediately and after 30 min in the post-anesthesia care unit (PACU), regarding Pediatric Anesthesia Emergence Delirium Scale (PAED)… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Magnesium Sulphate, Dexmedetomidine, Emergence Agitation
- What is being tested?
- Magnesium sulphate and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 10 Feb 2025
- Phase
- Interventional
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 4 to 8 years old.
- Both sexes.
- Patients American Society of Anesthesiologists (ASA) Physical Status I to II.
- Duration of surgery: not exceeding two hours
Who cannot join
- Legal guardian refusal.
- Neurological abnormalities, such as cerebral palsy.
- Any physical and/or developmental challenge.
- Patients on sedatives, anticonvulsants, or any medications that may alter conscious level in children.
- Coexisting renal or cardiovascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients Under Sevoflurane Anesthesia
This study aimed to compare the effectiveness of intraoperative magnesium sulfate versus dexmedetomidine infusions on emergence agitation that follows anesthesia using sevoflurane immediately and after 30 min in the post-anesthesia care unit (PACU), regarding Pediatric Anesthesia Emergence Delirium Scale (PAED), Richmond agitation sedation scale (RASS), and hemodynamics
Read the detailed description
Emergence agitation (EA) is a postoperative phenomenon that occurs in children after sevoflurane anesthesia, with an occurrence rate of up to 80%.
Dexmedetomidine acts on α-2 adrenergic receptors, producing sedation and hypnosis with anxiolytic effects, without a clinically significant depressive impact on heart rate, blood pressure, and respiratory rate, complementing an earlier study suggesting the possible effective and safe use of dexmedetomidine as a part of anesthesia care to prevent emergence agitation in children.
Magnesium sulfate also has been reported to decrease the incidence and severity of Emergence agitation and the need for postoperative rescue doses of analgesia in children, and its use was not associated with increased postoperative side effects or delayed recovery.
- Being tested
- Magnesium sulphate, Dexmedetomidine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
Patients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery.
DexmedetomidineDrug
Patients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate group | Experimental | Patients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery. Receives: Drug: Magnesium sulphate |
| Dexmedetomidine group | Experimental | Patients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium Scale
Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED Scale consists of five characteristics that are each scored by using a 5-point Likert scale:
- The child makes eye contact with the caregiver
- The child is aware of his or her surroundings
- The child's actions are purposeful,
- The child is restless
- The child is inconsolable We set the threshold score for the presence of pediatric emergence delirium using the PAED Scale at a score higher than or equal to 10 based on the sensitivity and specificity reported in the literature.
Measured: 30 minutes postoperatively
Secondary outcomes (3)
Richmond agitation sedation scale (RASS)
The Richmond agitation sedation scale (RASS) assesses five levels of sedation:
- (5) unarousable with no response to voice or physical stimulation
- (4) deep sedation with no response to voice but movement to physical stimuli
- (3) moderate sedation with movement to voice but no eye contact
- (2) light sedation and briefly awakens (ie, less than 10 seconds) with eye contact to voice
- (1) drowsy (ie, not fully alert) but has sustained (ie, more than 10 seconds) awakening with eye contact to voice
Measured: 30 minutes postoperatively
Heart rate
Heart rate will be recorded from the start of injection till 30 minutes postoperatively.
Measured: 30 minutes postoperatively
Blood pressure
Blood pressure will be recorded from the start of injection till 30 minutes postoperatively.
Measured: 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 posted18 May 2025
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium SulphateStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa medhat Ezzat Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977425
- Sponsor's protocol ID
- FMASU MS112/2024
- Status last verified
- May 2025
- First submitted
- 4 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients Under Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT06977425
- Acronym / sponsor ID
- FMASU MS112/2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 18 May 2025 (actual)
- 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.
This study aimed to compare the effectiveness of intraoperative magnesium sulfate versus dexmedetomidine infusions on emergence agitation that follows anesthesia using sevoflurane immediately and after 30 min in the post-anesthesia care unit (PACU), regarding Pediatric Anesthesia Emergence Delirium Scale (PAED), Richmond agitation sedation scale (RASS), and hemodynamics
Detailed description
Emergence agitation (EA) is a postoperative phenomenon that occurs in children after sevoflurane anesthesia, with an occurrence rate of up to 80%.
Dexmedetomidine acts on α-2 adrenergic receptors, producing sedation and hypnosis with anxiolytic effects, without a clinically significant depressive impact on heart rate, blood pressure, and respiratory rate, complementing an earlier study suggesting the possible effective and safe use of dexmedetomidine as a part of anesthesia care to prevent emergence agitation in children.
Magnesium sulfate also has been reported to decrease the incidence and severity of Emergence agitation and the need for postoperative rescue doses of analgesia in children, and its use was not associated with increased postoperative side effects or delayed recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate group | Experimental | Drug: Magnesium sulphatePatients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery. |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 4 to 8 years old.
- Both sexes.
- Patients American Society of Anesthesiologists (ASA) Physical Status I to II.
- Duration of surgery: not exceeding two hours
Key exclusion criteria (5 listed)
- Legal guardian refusal.
- Neurological abnormalities, such as cerebral palsy.
- Any physical and/or developmental challenge.
- Patients on sedatives, anticonvulsants, or any medications that may alter conscious level in children.
- Coexisting renal or cardiovascular diseases.
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 sulphatePatients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery. | Drug | Magnesium sulphate group |
| DexmedetomidinePatients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation. | Drug | Dexmedetomidine group |
Primary outcome
Pediatric Anesthesia Emergence Delirium Scale
Time frame: 30 minutes postoperatively
Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED Scale consists of five characteristics that are each scored by using a 5-point Likert scale: * The child makes eye contact with the caregiver * The child is aware of his or her surroundings * The child's actions are purposeful, * The child is restless * The child is inconsolable We set the threshold score for the presence of pediatric emergence delirium using the PAED Scale at a score higher than or equal to 10 based on the sensitivity and specificity reported in the literature.
3 secondary outcomes
Richmond agitation sedation scale (RASS)
Time frame: 30 minutes postoperatively
Heart rate
Time frame: 30 minutes postoperatively
Blood pressure
Time frame: 30 minutes postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulphate and Dexmedetomidine in people with Magnesium Sulphate and Dexmedetomidine, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anesthesia Emergence Delirium Scale (time frame: 30 minutes postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2025.