NCT05574179

Brief Summary

Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 6, 2022

Last Update Submit

October 6, 2022

Conditions

Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively

Outcome Measures

Primary Outcomes (1)

  • Dexmedetomidine is better sedative agent than midazolam in pediatric population

    25 minutes

Secondary Outcomes (2)

  • Midazolam is better sedating agent than dexmedetomidine in pediatric population

    25 minutes

  • Midazolam and dexmedetomidine are equally good sedating agents in pediatric population

    25 minutes

Study Arms (2)

midazola.

EXPERIMENTAL

Inj.midazolam

Drug: Midazolam

Dexnedetomidine

EXPERIMENTAL

inj.dexmedetomidine

Drug: Dexmedetomidine injection

Interventions

Dexmedetomidine injectionDRUG

Inj precedex 200mcg in 1ml given in stat doses

Also known as: Precidex
Dexnedetomidine
MidazolamDRUG

Inj.midazolam 5mg/5ml given in stat doses

midazola.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I and II Age 6 to 12 years Any gender

You may not qualify if:

  • ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexmedetomidineMidazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
early 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 Barzah durrani

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

January 1, 2023

Primary Completion

July 31, 2023

Study Completion

October 31, 2023

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From synopsis approval till completion of sample size