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To see the effect of 3 different doses of same drug called dexmedetomidine used to put the children to sleep before operation.

Evaluation of different doses of nebulised dexmedetomidine as premedication in children- a dose ranging clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019295
Enrollment
99
Registered
2019-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: H00-H59- Diseases of the eye and adnexa

Interventions

Intervention1: Dexmedetomidine 2mcg/kg: Group 2: Dexmed 2mcg/kg in 0.9% saline (3ml) nebulized over 15 minutes, 30 minutes before induction of anaesthesia. Intervention2: Dexmedetomidine 3mc/kg: Group

Sponsors

Postgraduate Institute of medical education and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 99 ASA I & II pediatric patients, in the age group of 3 - 7 years, undergoing general anesthesia

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to dexmedetomidine. Any obvious aberrant nasal anatomy Acute or chronic nasal trauma that may preclude adequate intranasal delivery of drug Patients with anticipated difficult airway Organ dysfunction-Liver dysfunction, Cardiac arrhythmias, congenital heart disease, mental retardation

Design outcomes

Primary

MeasureTime frame
Sedation scoreTimepoint: 30 minutes after nebulization

Secondary

MeasureTime frame
Emergence time, Emergence agitation, hemodynamic parameters, postoperative painTimepoint: In the postoperative period at immediate postoperative, 5 minutes, 15 minutes and 30 minutes, 1 hour and 2 hours after surgery.;Parental separation score, Mask acceptance scoreTimepoint: 2 minutes before induction of anaesthesia

Countries

India

Contacts

Public ContactDr Divya Jain

PGIMER

jaindivya77@rediffmail.com

Outcome results

None listed

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