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NCT05337085 Clinical Trial

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

Inguinal Hernia Clinical Trial

Official title:
To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05337085
Other study ID # AFarooqi
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date June 30, 2022
Est. completion date March 20, 2023

Study information
Verified date April 2022
Source Sheikh Zayed Medical College
Contact Anab Farooqi, MBBS
Phone 03337923232
Email zaibanaab94@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 185
Est. completion date March 20, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 15 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sheikh Zayed Medical College

Outcome
Type Measure Description Time frame Safety issue
Primary Level of sedation assessed through Ramsay Sedation Scale RSS 6 months
See also
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