Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair

Sheikh Zayed Medical College

Status and phase: Unknown; Phase 1

Conditions: Inguinal Hernia

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05337085

AFarooqi

Details and patient eligibility

About

To compare dexmedetomidine and midazolam for intra-op sedation in TIVA in children undergoing inguinal hernia repair. The results of the study if found significant will guide the anesthetist in appropriate choice and dose of sedative drug with highest efficacy and minimum side effects to avoid post operative adverse effects associated with anesthesia

Enrollment: 185 estimated patients

Sex: All

Ages: 12 months to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female paediatric patients In age range neonates to 15 years
• Planned for elective inguinal hernia repair
• Patients with uncomplicated hernia With ASA class I or II

Exclusion criteria

• Patients undergoing emergency inguinal repair
• Patients with ASA class III,IV,V or VI
• Patients present with complicated hernia
• Patients with BMI above 40kg/m2
• Patients with any allergy to anesthesia
• Patients with coagulopathy
• Patients with narcotic/opioid addiction

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

185 participants in 2 patient groups

Dexmedetomidine

Active Comparator group

Description:

Inj. Dexmedetomidine (precidex) 200/mcg/2ml given to participants in infusion form for 10 mins of surgery and maintenance dose given till the end of surgery

Treatment:

Drug: Dexmedetomidine

Midazolam

Active Comparator group

Description:

Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery

Treatment:

Drug: Midazolam