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

Primary Purpose

Inguinal Hernia

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam
Sponsored by
Sheikh Zayed Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inguinal Hernia

Eligibility Criteria

12 Months - 15 Years (Child)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Dexmedetomidine

    Midazolam

    Arm 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

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

    Outcomes

    Primary Outcome Measures

    Level of sedation assessed through Ramsay Sedation Scale RSS

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2022
    Last Updated
    April 19, 2022
    Sponsor
    Sheikh Zayed Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05337085
    Brief Title
    Comparison of Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
    Official Title
    To Compare Dexmedetomidine and Midazolam for Intra-op Sedation in TIVA in Children Undergoing Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    March 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheikh Zayed Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    185 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexmedetomidine
    Arm Type
    Active Comparator
    Arm 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
    Arm Title
    Midazolam
    Arm Type
    Active Comparator
    Arm Description
    Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    Inj dexmedetomidine and inj midazolam given to 2 groups of participants and sedative effects of both drugs will be observed during surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Intervention Description
    Midazolam
    Primary Outcome Measure Information:
    Title
    Level of sedation assessed through Ramsay Sedation Scale RSS
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anab Farooqi, MBBS
    Phone
    03337923232
    Email
    zaibanaab94@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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