Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Emergence Delirium

Treatments: Drug: Intranasal dexmedetomidine; Drug: Intranasal Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT04263844

IndonesiaUAnes 051

Details and patient eligibility

About

This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.

Full description

There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.

Enrollment: 66 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children undergoing ophthalmologic surgery with general anesthesia
• children aged 1 - 12 years old
• physical status ASA 1-2
• signing informed consent

Exclusion criteria

• children undergoing emergency surgery
• children with PICU nursing after surgery
• children with psychological and neurological condition
• children with allergic history to dexmedetomidine and midazolam
• children with history of malignant hyperthermia or family history of malignant hyperthermia
• children with possibility of difficult intubation and ventilation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 2 patient groups

Dexmedetomidine

Active Comparator group

Description:

subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction

Treatment:

Drug: Intranasal dexmedetomidine

Midazolam

Active Comparator group

Description:

subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction

Treatment:

Drug: Intranasal Midazolam