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Comparative study if intranasal dexmedetomidine is better than intravenous dexmedetomidine in reducing postoperative delirium in children undergoing elective surgery.

Intranasal versus Intravenous Dexmedetomidine for reducing emergence delirium in paediatric patients undergoing sevoflurane based anaesthesia A comparative double-blinded randomized trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093692
Enrollment
100
Registered
2025-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: Q620- Congenital hydronephrosis

Interventions

Intervention1: Intranasal instillation of dexmedetomidine drops in children undergoing elective surgery.: Group A patients will receive intranasal dexmedetomidine at a dose of 1 ?g/kg 30 minutes befor

Sponsors

IGIMS Patna
Lead Sponsor
Asad Reza
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged between 2 to 8 years. 2. Children with ASA grade I/II. 3. Children undergoing elective pediatric surgery. 4. Patient?s guardians willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patient?s guardians refusal to participate. 2.Children with allergy to dexmedetomidine. 3.Children with history of URTI. 4.Children with history of nasal obstruction. 5.Children with history of seizures. 6.Children with history of any cardiac problems.

Design outcomes

Primary

MeasureTime frame
Level of preoperative agitation (As per Aonos 4 point scale) 1-calm 2-not calm, but could be easily calmed 3- moderately agitated or restless 4- combative, excited, and disoriented. Intransal dexmedetomidine may be more convenient to use and of similar efficacy as compared to intravenous dexmedetomidine. Timepoint: Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU.—

Secondary

MeasureTime frame
Hemodynamic parameters HR, MAP, sPO2, ETCO2 at before injection, after injection, 5 minutes after start of surgery, 10 minutes after start of surgery, 15 minutes after start of surgery, 20 minutes after start of surgery, after extubation, before transferring to recovery, when arriving at the recovery, in 2nd 10 minutes of recovery, in 3rd 10 minutes of recovery. Frequency of ondansetron prescription.Timepoint: 5 minutes after start of surgery, 10 minutes after start of surgery, 15 minutes after start of surgery, 20 minutes after start of surgery, after extubation, before transferring to recovery, when arriving at the recovery, in 2nd 10 minutes of recovery, in 3rd 10 minutes of recovery.—

Countries

India

Contacts

Public ContactAsad Reza

IGIMS Patna

kumarnitin516@gmail.com8076070302

Outcome results

None listed

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