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

SINGLE BOLUS OF DEXMEDETOMIDINE VERSUS PROPOFOL FOR TREATMENT OF PEDIATRIC EMERGENCE DELIRIUM FOLLOWING GENERAL ANAESTHESIA- A RANDOMISED CONTROL TRIAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055336

Enrollment

Registered

2023-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K352- Acute appendicitis with generalized peritonitis Health Condition 2: H660- Acute suppurative otitis media Health Condition 3: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 4: N432- Other hydrocele Health Condition 5: F078- Other personality and behavioral disorders due to known physiological condition Health Condition 6: H490- Third [oculomotor] nerve palsy

Interventions

Intervention1: Assess efficacy of Dexmedetomidine & Propofol in Pediatric Emergence delirium undergoing General Anaesthesia.: To compare the efficacy of dexmedetomidine(0.5mcg/kg I.V) compared agains

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
At PACU, recovery time will be determined using ALDRETE Score after administration of either Dexmedetomidine or Propofol post emergence delirium (PAEDS SCORE)Timepoint: 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

Measure	Time frame
It includes the adverse events occurs post operatively & post administration of drugs Laryngospasm Desaturation Bradycardia PONV HypotensionTimepoint: post administration of drug(Dexmedetomidine or propofol) as per the PAEDS SCORE ,patients will be monitored for an hour for any adverse events as mentioned above(secondary outcome)	—

Countries

India

Contacts

Public ContactDr Monalisha Ganguly

Armed Forces Medical College, Pune

monagng@gmail.com8135915070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026