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

December 19, 2021 updated by: beshoy gamal, Ain Shams University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • ain shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Drug: Dexmedetomidine
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Active Comparator: Group B
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Drug: Magnesium Sulphate
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Other Names:
  • patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Placebo Comparator: Group C
Patients will receive Normal Saline 0.9% infusion
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cravero scale.
Time Frame: 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
up to one hour in Post-anesthesia care unit
Ramsay sedation scores (RSS)
Time Frame: 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
up to one hour in Post-anesthesia care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Anticipated)

November 7, 2022

Study Completion (Anticipated)

December 7, 2022

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

December 19, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 19, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams University hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD sharing plan will be available

IPD Sharing Time Frame

one year

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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