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Study to compare level of anxiety, sedation, fluctuation in vital parameters, smooth recovery from anesthesia and adverse effects after giving either dexmedetomidine or ketamine intranasaly prior to surgery in children

Comparative study of dexmedetomidine vs intranasal ketamine as premedicant in children

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/10/010269
Enrollment
100
Registered
2017-10-31
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: N489- Disorder of penis, unspecified

Interventions

Control Intervention1: Dexmedetomidine and Ketamine: To compare intranasal dexmedetomidine and intranasal ketamine as premdicant in children undergoing surgery Intranasal dexmedetomidine will be admin

Sponsors

Dept of anesthesiology IGIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA PS 1 2. Undergoing surgical procedures

Exclusion criteria

Exclusion criteria: Children with anticipated difficult airway BMI > 30 Liver or renal dysfunction Known allergy to dexmedetomidine OASS (Modified Observer Assessment of Alertness/Sedation Scale)

Design outcomes

Primary

MeasureTime frame
Sedation Score (Modified OASS) Maximum and Minimum heart rate (HR) at the time of induction Induction time will be from application of mask to securing airway 3 Mask acceptance score Adverse effects like Hypotension � Bradycardia Tachycardia Post operative shivering � PONV Emergence delirium Timepoint: Sedation Score (Modified OASS) Maximum and Minimum heart rate (HR) at the time of induction Induction time will be from application of mask to securing airway Mask acceptance score Adverse effects like � Hypotension � Bradycardia Tachycardia Post operative shivering � PONV � Emergence delirium

Secondary

MeasureTime frame
Effect of premedication on post operative recovery, emergence delirium and pain scoresTimepoint: 6 hrs post operative time

Countries

India

Contacts

Public ContactDr Nidhi Arun

Indira Gandhi Institute of medical Sciences

janya.mukesh@yahoo.com9523594059

Outcome results

None listed

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