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

NCT ID: NCT05337085

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-03-20

Brief Summary

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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

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam

Interventions

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Dexmedetomidine

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

Midazolam

Midazolam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anab Farooqi

Dr. Anab Farooqi

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Anab Farooqi, MBBS

Role: CONTACT

03337923232

Other Identifiers

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AFarooqi

Identifier Type: -

Identifier Source: org_study_id

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