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

Not Applicable

• Conditions: Postoperative Agitations in Pediatric Patients
• Interventions: Drug: Dexmedetomidine; Drug: Normal saline; Drug: Magnesium Sulphate

• Registration Number: NCT05164627
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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) .

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-11-26
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-19
• Last Update Submitted: 2021-12-19
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21
• Primary Completion: 2022-11-07
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Dexmedetomidine	patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Group C	Normal saline	Patients will receive Normal Saline 0.9% infusion
Group B	Magnesium Sulphate	patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.

Primary Outcome Measures

Name	Time	Method
The Cravero scale.	up to one hour in Post-anesthesia care unit	it has five steps from obtunded and unresponsive to wild thrashing behaviour requiring restraint. A score of ≥4 (from crying and difficult to console to wild thrashing) for a 5 or more min duration despite active calming efforts is regarded as indicative of ED.; Behaviour Score Obtunded with no response to stimulation 1 Asleep but responsive to movement or stimulation 2 Awake and responsive 3 Crying (for \>3 min) 4 Thrashing behaviour that requires restraint 5
Ramsay sedation scores (RSS)	up to one hour in Post-anesthesia care unit	1. Patient is anxious and agitated or restless, or both; 2. Patient is co-operative, oriented, and tranquil; 3. Patient responds to commands only; 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6. Patient exhibits no response

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt