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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06077539

Collaborator

(none)

100

Enrollment

Location

Arms

7.4

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

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).(

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Emergence Delirium	Drug: Dexmedetomidine Drug: Ketamine Drug: Magnesium Other: normal saline 0.9% NaCL	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.(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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Health Services Research

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.

Actual Study Start Date :

Sep 20, 2023

Anticipated Primary Completion Date :

Apr 15, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine group 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.	Drug: Dexmedetomidine a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects.
Active Comparator: Magnesium group 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).	Drug: Magnesium NMDA (N-methyl-D-aspartate) receptor antagonist
Active Comparator: Ketamine group 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	Drug: Ketamine NMDA (N-methyl-D-aspartate) receptor antagonist
Placebo Comparator: Control group 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.	Other: normal saline 0.9% NaCL saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups

Outcome Measures

Primary Outcome Measures

PAED scale 15 min postoperatively [15 minutes]
pediatric anesthesia emergence delirium

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts 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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amany Hassan Saleh	Giza		Egypt	02

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Amany Saleh, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amany Hassan Saleh, Assistant professor of anesthesia ,surgical intensive care and pain management, Cairo University

ClinicalTrials.gov Identifier:

NCT06077539

Other Study ID Numbers:

N-122-2023

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergence Delirium

Dexmedetomidine

Ketamine

Study Results

No Results Posted as of Oct 11, 2023