ASA Physical Status I, ASA Physical Status II, Elective Surgical Procedure
Conditions
Keywords
intranasal dexmedetomidine
Brief summary
The purpose of this study is to find out if a medicine called dexmedetomidine, given as a nasal spray, can help patients stay calm and comfortable before having a breathing tube placed (intubation). Researchers want to see if using this nasal spray affects blood pressure, heart rate, comfort with the oxygen mask, how quickly the tube is placed, and how sleepy patients become. They also want to check if patients who receive dexmedetomidine need less pain medicine (Fentanyl) during the procedure. Participants will receive either the dexmedetomidine nasal spray or a plain saltwater spray (placebo). Doctors will then measure blood pressure, heart rate, comfort levels, time needed for intubation, sleepiness, and the amount of pain medication used.
Interventions
DRUGIntranasal dexmedetomidine
Intranasal dexmedetomidine at a dose of 2 mcg/kg body weight, diluted in 1 mL of 0.9% NaCl, administered using a 1 mL syringe connected to a Teleflex MAD Nasal device while in the supine position. The soft tip of the device will be gently placed into each nostril without applying pressure. The solution will be sprayed slowly to create a fine mist. The total dose will be divided equally, with 0.5 mL delivered into each nostril, administered approximately 30 minutes before intubation during induction.
Participants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a Teleflex MAD nasal device while in the supine position. The soft tip of the Teleflex MAD nasal device is gently placed into each nostril without applying pressure. The solution is slowly sprayed to create a fine mist for patient comfort. The dose is divided equally, delivering 0.5 ml into each nostril, approximately 30 minutes before intubation during induction.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 1-6 years undergoing elective surgery * ASA physical status 1 and 2
Exclusion criteria
* Children with difficult airway * Active infection in nasal and oral area * Subjects with mental retardation, ADHD, and cerebral palsy * Difficult intravenous access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure | immediately before premedication and immediately after intubation | Measured by non-invasive blood pressure monitoring |
| Heart rate | immediately before premedication and immediately after intubation | Measured by electrocardiography electrodes in vital sign monitor |
| Mask acceptance | Before induction | Measured using the Pediatric Anesthesia Behavior (PAB) scale. The PAB scale range from 1 to 3, with 1 indicating the best outcome (happy) and 3 the worst outcome (mad). |
| Intubation duration | during intubation | Measured using stopwatch, in seconds Started when inserting laryngoscope into the mouth, ended when end tidal CO2 is detected by the monitor |
| Sedation Score | Immediately upon arrival to the operating room, before induction of anesthesia | Sedation level was assessed using the COMFORT Behaviour Scale, which evaluates the child's sedation state after administration of dexmedetomidine. The total score ranges from 6 to 30, with the following interpretations: * Excessive sedation: 6-10 * Adequate sedation: 11-22 * Inadequate sedation: 23-30 Higher scores indicate less effective sedation control, whereas lower scores reflect deeper sedation. |
| Opioid use | Immediately after intubation | Amount of fentanyl (per kg body weight) used during intubation |
Countries
Indonesia
Outcome results
None listed