Efficacy of Dexmedetomidine Nebulization in preventing post anaesthetic agitation in children

Efficacy of Dexmedetomidine Nebulization in preventing sevoflurane induced Emergence Agitation in Children: A Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089626

Enrollment

120

Registered

2025-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: R69- Illness, unspecified

Interventions

Intervention1: DEXMEDETOMIDINE NEBULISATION: INTRA OPERATIVE NEBULISATION 30 min prior the closure of surgery WITH DRUG IN 2 GROUPS A-0.5MCG/KG OF DRUG B-1MCG/KG OF DRUG frequency: once route of admi

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II Patients. Both genders. Patients in the age group of 2-8 years. Patients undergoing elective surgery under GA with sevoflurane for maintenance of anesthesia

Exclusion criteria

Exclusion criteria: Patientâ??s parent/guardian refusal. Child with development delay. Anticipated difficult intubation. Patient having h/o asthma, known allergy to the drug, or any cardiac disease. Usage of Inhalational induction. Patients on infusion Propofol and/or Dexmedetomidine for maintenance of anesthesia. Patients requiring post operative ventilatory support.

Design outcomes

Primary

Measure	Time frame
To find out whether nebulization with dexmedetomidine helps in reducing the incidence of emergence agitation in children after general anaesthesia with sevoflurane.Timepoint: Emergence agitation is measured using CRAVERO scale at 30 min, 45 min & at 60 min of Nebulization. In case of prolonged extubation (beyond 45 min after nebulization), Emergence agitation will be recorded at the time of extubation.	—

Measure

Time frame

To find out whether nebulization with dexmedetomidine helps in reducing the incidence of emergence agitation in children after general anaesthesia with sevoflurane.Timepoint: Emergence agitation is measured using CRAVERO scale at 30 min, 45 min & at 60 min of Nebulization. In case of prolonged extubation (beyond 45 min after nebulization), Emergence agitation will be recorded at the time of extubation.

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Secondary

Measure	Time frame
1. To compare the efficacy of two doses of Dexmedetomidine nebulization. 2. To find out incidence of any adverse event after Dexmedetomidine nebulization (in peri-operative period). Timepoint: Emergence agitation using CRAVERO scale at 30 min, 45 min & at 60 min of Nebulization. Vitals parameter- HR, BP, SPO2, RR at 30min, 45 min & at 60 min of Nebulization. In case of prolonged extubation (beyond 45 min after nebulization), Emergence agitation & Hemodynamic parameters will be recorded at the time of extubation.	—

Measure

Time frame

1. To compare the efficacy of two doses of Dexmedetomidine nebulization. 2. To find out incidence of any adverse event after Dexmedetomidine nebulization (in peri-operative period). Timepoint: Emergence agitation using CRAVERO scale at 30 min, 45 min & at 60 min of Nebulization. Vitals parameter- HR, BP, SPO2, RR at 30min, 45 min & at 60 min of Nebulization. In case of prolonged extubation (beyond 45 min after nebulization), Emergence agitation & Hemodynamic parameters will be recorded at the time of extubation.

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Countries

India

Contacts

Public ContactAARTI AGARWAL

SGPGIMS

aarti_agarwal000@yahoo.co.uk8765974039

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026