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

April 19, 2022 updated by: Anab Farooqi, Sheikh Zayed Medical College

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

185

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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
Drug: Dexmedetomidine
Inj dexmedetomidine and inj midazolam given to 2 groups of participants and sedative effects of both drugs will be observed during surgery
ACTIVE_COMPARATOR: Midazolam
Inj midazolam 0.5 mg/kg stat dose will be given to participants during surgery
Drug: Midazolam
Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of sedation assessed through Ramsay Sedation Scale RSS
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 30, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

March 20, 2023

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (ACTUAL)

April 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFarooqi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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