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

Primary Purpose

Postoperative Agitations in Pediatric Patients

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Magnesium Sulphate
Normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Agitations in Pediatric Patients focused on measuring Dexmedetomidine, Magnesium Sulphate, Agitations

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts 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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Group C

Arm Description

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

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

Patients will receive Normal Saline 0.9% infusion

Outcomes

Primary Outcome Measures

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
Ramsay sedation scores (RSS)
Patient is anxious and agitated or restless, or both Patient is co-operative, oriented, and tranquil Patient responds to commands only Patient exhibits brisk response to light glabellar tap or loud auditory stimulus Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus Patient exhibits no response

Secondary Outcome Measures

Full Information

First Posted
November 26, 2021
Last Updated
December 19, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05164627
Brief Title
Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy
Official Title
Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
November 7, 2022 (Anticipated)
Study Completion Date
December 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Agitations in Pediatric Patients
Keywords
Dexmedetomidine, Magnesium Sulphate, Agitations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Patients will receive Normal Saline 0.9% infusion
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulphate
Other Intervention Name(s)
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Intervention Description
patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
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
Primary Outcome Measure Information:
Title
The Cravero scale.
Description
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
Time Frame
up to one hour in Post-anesthesia care unit
Title
Ramsay sedation scores (RSS)
Description
Patient is anxious and agitated or restless, or both Patient is co-operative, oriented, and tranquil Patient responds to commands only Patient exhibits brisk response to light glabellar tap or loud auditory stimulus Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus Patient exhibits no response
Time Frame
up to one hour in Post-anesthesia care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD sharing plan will be available
IPD Sharing Time Frame
one year
Citations:
PubMed Identifier
16324031
Citation
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.
Results Reference
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Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy

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