Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Intranasal Dexmedetomidine: Intranasal dexmedetomidine 2 microgram per kilogram administered 30 minutes prior to induction of anesthesia using mucosal atomization device.
Control Interv
Sponsors
LLRM Medical College, Meerut
Eligibility
Inclusion criteria
Inclusion criteria: Children aged two to ten years of either gender belonging to American Society of Anesthesiologists physical status one or two scheduled for elective surgery under general anaesthesia with parental consent.
Exclusion criteria
Exclusion criteria: Children with known hypersensitivity or contraindication to midazolam or dexmedetomidine. Presence of upper respiratory tract infection, nasal obstruction, recent nasal surgery, or significant nasal pathology. Developmental delay, neurological disorder, or psychiatric illness likely to affect sedation assessment. Significant cardiovascular, respiratory, hepatic, or renal disease. Receipt of sedatives, anticonvulsants, or psychotropic medication within the previous forty eight hours. Emergency surgical procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation score assessed using the Modified Observer Assessment of Alertness Sedation scale.Timepoint: At baseline before drug administration and at 10 20 and 30 minutes after intranasal drug administration prior to induction of anaesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parental separation anxiety score.Timepoint: At the time of separation from parents before induction of anaesthesia.;Mask acceptance score.Timepoint: At the time of induction of anaesthesia.;Perioperative haemodynamic parameters including heart rate blood pressure and oxygen saturation.Timepoint: At baseline and at 5 10 20 and 30 minutes after drug administration.;Incidence of adverse effects including bradycardia hypotension desaturation nausea and vomiting.Timepoint: Throughout perioperative period. | — |
Countries
India
Contacts
Public ContactDr Vishal Kumar Singh
LLRM Medical College, Meerut
Outcome results
None listed