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

NCT05337085 | Unknown Phase 1 DMC

• 1 other identifier: AFarooqi
• Study Type: interventional
• Target: 185
• Locations: 0 countries
• Sites: N/A

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

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• Level of sedation assessed through Ramsay Sedation Scale RSS

  6 months

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Inj dexmedetomidine and inj midazolam given to 2 groups of participants and sedative effects of both drugs will be observed during surgery

Dexmedetomidine

Midazolam DRUG

Midazolam

Midazolam

Eligibility Criteria

• Age: 12 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Anab Farooqi, MBBS

CONTACT

03337923232; zaibanaab94@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Anab Farooqi

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 20, 2022
• Study Start: June 30, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 20, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share