Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Phase 4

Not yet recruiting

• Conditions: Anesthesia
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT06181682
• Lead Sponsor: Ain Shams University

Brief Summary

compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Study Start: 2024-01
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Children of preschool age (2-6 years old).
• American scocity of anaesthesiology (ASA) I - II children.
• Expected duration of the procedure is less than 50 minutes.

Exclusion Criteria

• Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction.
• Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).
• Regular intake of either brain stimulant or depressive drugs (example: Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).
• Parent's refusal.
• Emergency case.
• Allergy to any of the used drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Dexmedetomidine	patients will receive intranasal dexmedetomidine (1 microgram/kg) -Intranasal dexmedetomidine will be prepared from the 100 mcg/ml parenteral preparation in a 1-ml syringe, and 0.9% saline will be added to make a final volume of 1 ml- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.
midazolam group	Midazolam	patients will receive intranasal midazolam (0.2 mg/kg) up to 5 mg - Intranasal midazolam will be prepared from a 5 mg/ml parenteral preparation, and 0.9% saline will be added to make a final volume of one ml in a 1-ml syringe- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.

Primary Outcome Measures

Name	Time	Method
Sedation status at separation from the parent	within 30 minutes after drugs administration	Parental separation anxiety scale (PSAS) ,A score of 1-2 was considered "satisfactory separation" and a score of 3-4 was considered "unsatisfactory separation."

Secondary Outcome Measures

Name	Time	Method
Onset of sedation	within 30 minutes after drugs administration	Onset of sedation will be recorded according to Modified RAMSAY Sedation Scale when the score reaches 3 points, patient is then ready to be transferred.
awakening time	within 15 minutes after end of anaesthesia	recovery time (defined as return of consciousness, recovery of protective air way reflexes and resumption of motor activity)
post-operative emergence delirium and agitation.	within 30 minutes from recovery	(PAED) scale: Pediatric Anesthesia Emergence Delirium (PAED) scales. scale from 0 to 20. higher scores mean a worse outcome