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

Phase 1

• Conditions: Inguinal Hernia
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT05337085
• Lead Sponsor: Sheikh Zayed Medical College

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-19
• Last Update Submitted: 2022-04-19
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20
• Study Start: 2022-06-30
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 185

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	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
Midazolam	Midazolam	Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery

Primary Outcome Measures

Name	Time	Method
Level of sedation assessed through Ramsay Sedation Scale RSS	6 months