Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy
NCT ID: NCT05164627
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-01-08
2022-12-07
Brief Summary
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Secondary outcome is to reduce child needs for analgesics and to reduce their dose.
Detailed Description
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Monitors for non-invasive blood pressure, heart rate, electrocardiogram (ECG), pulse oximetry (SpO2) will be attached. Induction of anesthesia will be done using 8% Sevoflurane in oxygen gas with Atracurium 0.5 mg/kg and fentanyl 0.5 mcg/kg to facilitate tracheal intubation. The patients will be divided into three groups:
oGroup A (Dexmedetomidine Group): patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
oGroup B (Magnesium Group): patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
oGroup C (Control Group): Patients will receive Normal Saline 0.9% infusion
Maintenance of anesthesia will be done by using of Sevoflurane 2% in oxygen gas. Controlled mechanical ventilation will be done to maintain normocapnia. Rescue doses of Fentanyl (0.5 mcg/kg) will be given if the patient develop pain. Intraoperative pain is defined as development of Tachycardia (\> 20% of baseline heart rate reading) and Hypertension (\>20% of Baseline Mean Arterial Blood Pressure reading) .
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Dexmedetomidine
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Group B
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Magnesium Sulphate
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Group C
Patients will receive Normal Saline 0.9% infusion
Normal saline
After patient arrival at the PACU, Paediatric Anaesthesia Emergence Delirium (PAED) scale ,Ramsay sedation scores (RSS), emergence agitation, HR, and mean arterial blood pressure (MAP) were recorded every 5 min during the first 30 min, then every 10 min for the remaining 30 min of the recovery room stay. Patients were then transferred to the ward. All postoperative observations and scores were performed by the same anesthesiologist who was blinded to the group assignment
Interventions
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Dexmedetomidine
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Magnesium Sulphate
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Normal saline
After patient arrival at the PACU, Paediatric Anaesthesia Emergence Delirium (PAED) scale ,Ramsay sedation scores (RSS), emergence agitation, HR, and mean arterial blood pressure (MAP) were recorded every 5 min during the first 30 min, then every 10 min for the remaining 30 min of the recovery room stay. Patients were then transferred to the ward. All postoperative observations and scores were performed by the same anesthesiologist who was blinded to the group assignment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age group: 4-12 years old.
* The procedure expected to be completed within 1 hour.
Exclusion Criteria
* lack of consent.
* known adverse effects to dexmedetomidine.
* Mental retardation developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure..etc.)
* Hemodynamically unstable patients.
* Persistent cough or high airway secretions.
* Clinical signs of active infectious disease.
* Coagulopathy (INR \>1.5).
* Obesity (BMI \>30 Kg/m2 ).
* Surgical complication
4 Years
12 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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beshoy gamal
principal investigator
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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Shukry M, Clyde MC, Kalarickal PL, Ramadhyani U. Does dexmedetomidine prevent emergence delirium in children after sevoflurane-based general anesthesia? Paediatr Anaesth. 2005 Dec;15(12):1098-104. doi: 10.1111/j.1460-9592.2005.01660.x.
Other Identifiers
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Ain Shams University hospital
Identifier Type: -
Identifier Source: org_study_id