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

NCT05164627 | Unknown DMC

• 1 other identifier: Ain Shams University hospital
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Agitations in Pediatric Patients

Keywords

Dexmedetomidine, Magnesium Sulphate, Agitations

Outcome Measures

Primary Outcomes (2)

• The Cravero scale.

  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

  up to one hour in Post-anesthesia care unit

• Ramsay sedation scores (RSS)

  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

  up to one hour in Post-anesthesia care unit

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Group B

ACTIVE COMPARATOR

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

Drug: Magnesium Sulphate

Group C

PLACEBO COMPARATOR

Patients will receive Normal Saline 0.9% infusion

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

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

Group A

Magnesium Sulphate DRUG

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

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

Group B

Normal saline DRUG

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

Group C

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (1)

• 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.

  PMID: 16324031 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 21, 2021
• Study Start: January 8, 2021
• Primary Completion: November 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one year

Locations

EG (1)