search
Back to results

Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics

Primary Purpose

Anesthesia Emergence Delirium

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Ketamine
Magnesium
normal saline 0.9% NaCL
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anesthesia Emergence Delirium

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA physical status II ages from 2-5 years. weight more than 6 kg. scheduled for cardiac catheterization procedure not exceeding 3 hours. Exclusion Criteria: psychological disorder or cognitive delay. chronic or acute intake of any sedative drug or anticonvulsant drugs. Any neurological condition that will limit ability to communicate with, or understand a practitioner. those with coexisting renal diseases , any reported allergy to the given medications. legal guardian refusal .

Sites / Locations

  • Amany Hassan SalehRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine group

Magnesium group

Ketamine group

Control group

Arm Description

25 patients will receive Dexmedetomidine 1 μg/kg bolus over 10 min followed by 0.5 μg/kg/h as maintenance volume-matched 0.9% saline.

25 patients will receive IV magnesium as a loading dose 15 mg/kg diluted in 0.9% NaCl given over 10 min followed by 10mg/kg/h IV infusion( for Concentration of solution will not exceed 1gm/25 mL (40 mg/ml).

25 patients will receive intravenous (IV) ketamine 1mg/kg diluted in 0.9% NaCl as a loading dose over 10min then 1mg/kg/h IV infusion

in 25 patients saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups.

Outcomes

Primary Outcome Measures

PAED scale 15 min postoperatively
pediatric anesthesia emergence delirium

Secondary Outcome Measures

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT06077539
Brief Title
Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics
Official Title
Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics : A Prospective, Double-blinded, Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Emergence agitation (EA) is a post-operative behavioral disturbance was first reported in early 1960s. EA is a term used to describe non purposeful restlessness and agitation, thrashing, crying or moaning, disorientation and incoherence during early stage of recovering from general anesthesia in children, especially those receiving sevoflurane. Generally, the incidence of EA following sevoflurane anesthesia varies from 10% to 66% and is more common in pre-school children. EA is generally short lived without obvious aftereffect. However, it still accompanies with risk of self-injury, and requires extra nursing care, which may delay the discharge and increase the cost of medical care Emergence agitation is diagnosed by a final composite score of greater than or equal to 10 on the Pediatric Anesthesia Emergence Delirium Scale (PAED).(
Detailed Description
Sevoflurane induced anesthesia does not cause significant cardiac depression and dysrrhythmias as compared to halothane. Sevoflurane anesthesia is also easy to titrate for maintaining an adequate level of anesthesia, especially for the intubated. It also is a potent bronchodilator, which can offer an added benefit especially in children with a history of asthma. For all above reasons sevoflurane has clearly become the inhalation induction agent of choice. The exact reasons for a higher incidence of EA with sevoflurane are not well explained. seizure activity in previously nonepileptic patients has been detected with electroencephalography during sevoflurane anesthesia. One of the proposed treatments for EA is the use of opioids; however, it carries the risk of an extended Post Anesthetic Care Unit (PACU) stay resulting in parents' discomfort and added costs. Therefore, analgesic adjuvants with NMDA (N-methyl-D-aspartate) receptor antagonist functions, such as ketamine and magnesium sulfate have been tried to control this phenomenon in children. Also, Dexmedetomidine, a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects. It was proved that α2 agonists decrease emergence agitation by their analgesic effect as well as by minimizing the anesthetic requirements. In the review of literature this is the first study comparing the effectiveness of the three drugs ketamine, magnesium sulfate and dexmedetomidine infusions together in one study on the incidence of emergence agitation after sevoflurane induced anesthesia in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Emergence Delirium

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
(100) patients will be randomized into four equal groups using computer-generated block randomization and there will be five blocks each block contains 5 patients in each group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The anesthesiologist not involved in the study will open envelopes and will prepare the drug. All syringes will be prepared by the same investigator not one of the study researchers. Administration of anesthesia and study drugs will be made by other investigators blinded to the study drugs and not involved in the study. Data collection will be done by investigator who is included in the study.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
25 patients will receive Dexmedetomidine 1 μg/kg bolus over 10 min followed by 0.5 μg/kg/h as maintenance volume-matched 0.9% saline.
Arm Title
Magnesium group
Arm Type
Active Comparator
Arm Description
25 patients will receive IV magnesium as a loading dose 15 mg/kg diluted in 0.9% NaCl given over 10 min followed by 10mg/kg/h IV infusion( for Concentration of solution will not exceed 1gm/25 mL (40 mg/ml).
Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
25 patients will receive intravenous (IV) ketamine 1mg/kg diluted in 0.9% NaCl as a loading dose over 10min then 1mg/kg/h IV infusion
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
in 25 patients saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
NMDA (N-methyl-D-aspartate) receptor antagonist
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
NMDA (N-methyl-D-aspartate) receptor antagonist
Intervention Type
Other
Intervention Name(s)
normal saline 0.9% NaCL
Intervention Description
saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups
Primary Outcome Measure Information:
Title
PAED scale 15 min postoperatively
Description
pediatric anesthesia emergence delirium
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status II ages from 2-5 years. weight more than 6 kg. scheduled for cardiac catheterization procedure not exceeding 3 hours. Exclusion Criteria: psychological disorder or cognitive delay. chronic or acute intake of any sedative drug or anticonvulsant drugs. Any neurological condition that will limit ability to communicate with, or understand a practitioner. those with coexisting renal diseases , any reported allergy to the given medications. legal guardian refusal .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amany H Saleh, MD
Phone
01224259808
Email
dr_amanyhassan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Passaint H Fahim, MD
Phone
01000990952
Email
passaintf@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany Saleh, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amany Hassan Saleh
City
Giza
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amany H Saleh, MD
Phone
1224259808
Email
dr_amanyhassan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Passaint H Fahim, MD
Phone
01000990952
Email
passaintf@yahool.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics

We'll reach out to this number within 24 hrs