Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

NCT05766436 | Unknown DMC

• 1 other identifier: FWA 000017585
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.

Conditions

Anxiety Acute; Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• perioperative anxiety

  perioperative anxiety will be measured by using Parental separation anxiety scale (PSAS) will be calculated according to the following: * Behavior of the child during separation from parents will be Excellent if the Patient unafraid, cooperative, or asleep will be given the score of (1) * Behavior of the child during separation from parents will be Good if the patient is Slightly afraid/crying, quiet with reassurance will be given the score (2) * Behavior of the child during separation from parents will be Fair if the patient is Moderately afraid and crying not quit with reassurance with the score (3) * Behavior of the child during separation from parents will be poor if the patient is Crying, need for restraint with the score (4) the score of (1) means excellent response , score of (2) means good response , score of (3) means fair response and score of (4) means poor response

  during the patient separation from the caregiver just as the child is going to the operating theater

Secondary Outcomes (3)

• mask acceptance

  during the mask introduction to start inhalational induction of anesthesia with sevoflurane before skin incision

• post anesthesia emergence agitation

  first 15 minutes after admission to post- anesthesia care unit

• pain score

  during hospital stay up to 3 hours

Study Arms (3)

group D

ACTIVE COMPARATOR

will receive placebo ODF and nebulized dexmedetomidine (Precedex™ rxlist)

Drug: Dexmedetomidine

group M

ACTIVE COMPARATOR

will receive placebo nebulizer and ODF melatonin (metacyst ™ nerhadou)

Drug: Melatonin

group C

PLACEBO COMPARATOR

will receive placebo ODF and placebo 0.9% normal saline nebulizer

Drug: Placebo

Interventions

Dexmedetomidine DRUG

receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.

Also known as: Precedex™ rxlist

group D

Melatonin DRUG

will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining

Also known as: metacyst ™ nerhadou

group M

Placebo DRUG

placebo ODF and 0.9% normal saline nebulizer

Also known as: normal saline

group C

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients of American Society of Anesthesiologists (ASA) physical status I \& II
• both genders,
• ≥ 2 to 10 years,
• scheduled for elective day case surgery under general anesthesia

You may not qualify if:

• parents' refusal for participation in the study
• ASA III and VI patients with history of chronic illness
• runny nose or upper respiratory tract infection
• Emergency surgeries with hemodynamic instability
• history of allergic reaction to dexmedetomidine or melatonin
• History of prematurity
• developmental delay
• central nervous system disorder,
• mental retardation,
• neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.).
• treatment with anticonvulsants and sedatives

Sponsors & Collaborators

• nada moahmed aboelrouse: lead

Study Sites (1)

Ain shams university hospital

Cairo, Abbasia, 11213, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Melatonin; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sohair Abbas, MD

  Ain Shams University, Anesthesia department

  STUDY CHAIR

• Ramy Mahrose, MD

  Ain Shams University, Anesthesia department

  STUDY DIRECTOR

• Wessam Zaher, MD

  Ain Shams University, Anesthesia department

  STUDY DIRECTOR

Central Study Contacts

Nada M Aboelrouse, masters

CONTACT

00201003371346; nadaaboelrouse21@gmail.com

Mohamed A Tolba, MD

CONTACT

0020115 6622298; Mohamedtolba@med.asu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: March 13, 2023
• Study Start: March 15, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)