Comparison of two different doses of Dexmedetomidine versus Nalbuphine in attenuation of Sevoflurane associated emergence agitation in paediatric patients undergoing hypospadias repair

Comparison of two different doses of Dexmedetomidine versus Nalbuphine in attenuation of Sevoflurane associated emergence agitation in paediatric patients undergoing hypospadias repair- a hospital based randomised controlled trial - NILL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/079982

Enrollment

Registered

2025-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: N99- Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified Health Condition 2: N99- Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified

Interventions

Intervention1: Administration of 2 different doses of Dexmedetomidine and 1 dose of nalbuphine in the attenuation of emergence agitation from sevoflurane anaesthesia: Two different doses of Dexmedeto

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status I and II. 2. Age between 2 to 10 years. 3. Patients undergoing lower abdominal surgeries 4. Operation time less than or equal to 1 hour.

Exclusion criteria

Exclusion criteria: 1. Risk of aspiration 2. Known difficult airway 3. Patients with Upper and Lower respiratory tract infections 4. Congenital malformations involving respiratory tract 5. History of epilepsy 6. Patients with cardiac, renal or liver diseases 7. Patients with allergy to the study drug 8. Cervical spine disease 9. Patients with bleeding and coagulation disorders 10. Patients receiving digoxin 11. Preoperatively agitated child

Design outcomes

Primary

Measure	Time frame
To compare effects of 0.3 mcg/kg of Dexmedetomidine IV , 0.5 mcg/kg of Dexmedetomidine IV versus 0.1 mg/kg of Nalbuphine IV in attenuation of emergence agitation resulting from the use of Sevoflurane, in paediatric patients undergoing Hypospadias repair.Timepoint: BASELINE VALUE 0 MIN IN PACU 5 MIN 10 MIN 20 MIN 30 MIN 40 MIN	—

Secondary

Measure	Time frame
To assess the Ramsay sedation score and Pain score of 0.3 mcg/kg Dexmedetomidine IV, 0.5mcg/kg Dexmedetomidine IV and 0.1 mg/kg Nalbuphine IV and their post operative hemodynamic parameters.Timepoint: BASELINE VALUE 0 MIN IN PACU 5 MIN 10 MIN 20 MIN 30 MIN 40 MIN	—

Countries

India

Contacts

Public ContactDr Tejasvini Kalathuru

Jawaharlal Nehru Medical College, Belgaum, Karnataka, India-590010

drmontygoudar@yahoo.co.in9962728749

Outcome results

None listed

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