Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy

Ain Shams University

Status: Unknown

Conditions: Postoperative Agitations in Pediatric Patients

Treatments: Drug: Normal saline; Drug: Magnesium Sulphate; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05164627

Ain Shams University hospital

Details and patient eligibility

About

The aim of this study is evaluating the efficacy and safety of dexmedetomidine versus Magnesium for reducing emergence agitation after adenotonsillectomy in children.

Secondary outcome is to reduce child needs for analgesics and to reduce their dose.

Full description

Preoperatively, Intravenous access using EMLA cream will be established in the ward. Child will be introduced to information about GA, OR and surgery. This information will include pictures of the staff and the OR, facemask, blood pressure cuff, etc. The child will move from ward to Pre-Anesthesia Care Unit accompanying his/her parents and anesthesia doctor to establish bonding. Cooperation on induction will be evaluated by using four-point scale with score of 1 to 2 being satisfactory and 3 to 4 being unsatisfactory. If the child develop agitation (Score 3 or 4) emergency Midazolam 0.1 mg/kg IV will be given and the child will be ruled out of study.

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) .

Enrollment: 40 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I or II.
• Age group: 4-12 years old.
• The procedure expected to be completed within 1 hour.

Exclusion criteria

• Patients with expected difficult airway management.
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups, including a placebo group

Group A

Active Comparator group

Description:

patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.

Treatment:

Drug: Dexmedetomidine

Group B

Active Comparator group

Description:

patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.

Treatment:

Drug: Magnesium Sulphate

Group C

Placebo Comparator group

Description:

Patients will receive Normal Saline 0.9% infusion

Treatment:

Drug: Normal saline