MedPath

To understand the effectivesness of the drugs for paediatric emergence delirium after General Anaesthesia by comparison method scores

Phase 3
Not yet recruiting
Conditions
Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: N432||Other hydrocele, (3) ICD-10 Condition: F078||Other personality and behavioral disorders due to known physiological condition, (4) ICD-10 Condition: K352||Acute appendicitis with generalized peritonitis, (5) ICD-10 Condition: H660||Acute suppurative otitis media, (6) ICD-10 Condition: H490||Third [oculomotor] nerve palsy,
Registration Number
CTRI/2023/07/055336
Lead Sponsor
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE AFMC PUNE
Brief Summary

The various studies conducted in different set up in which the comparison for the efficacy of Dexmedetomidine & Propofol was established in the treatment of Pediatric Emergence Delirium undergoing General Anaesthesia, concluded that both the drugs decreased the incidence of Emergence Delirium. However, the studies have been inconclusive in determining a better modality in other countries. Therefore, such studies need relevant data & further extrapolation in the Indian subcontinent.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
82
Inclusion Criteria

(a)Patients undergoing major surgeries (b)Age more than 1year & less than 12 years (c) ASA Grade I & II.

Exclusion Criteria

(a) Patients on sedatives/hypnotics pre-operatively (b)Patients with developmental delay (c)Pre-existing neurological disorders (d) Altered sensorium, unable to tolerate overnight fasting (e)History of allergic reactions to used medications (f)Associated with Psychiatric illness/cardiac illness.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
At PACU, recovery time will be determined using ALDRETE Score after administration of either Dexmedetomidine or Propofol post emergence delirium (PAEDS SCORE)Recovery time is interval between arrival at PACU to reaching ALDRETE SCORE more than 9.this is in immediate post extubation period when child was being monitored for pediatric emergence delirium for 30min.
Secondary Outcome Measures
NameTimeMethod
It includes the adverse events occurs post operatively & post administration of drugsLaryngospasm

Trial Locations

Locations (1)

ARMED FORCES MEDICAL COLLEGE PUNE

🇮🇳

Pune, MAHARASHTRA, India

ARMED FORCES MEDICAL COLLEGE PUNE
🇮🇳Pune, MAHARASHTRA, India
LT COL GUNJAN
Principal investigator
9612112136
gunjanafmc@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.