Comparison of Sedative Effect of Dexmedetomidine and Mida... | NCT05574179

Studies
Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA

NCT05574179

Sponsor

Sheikh Zayed Medical College

Status

Unknown status

Last Update Posted

Oct 10, 2022Actual

Enrollment

60Estimated

Phase

Early Phase 1

Conditions

Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively

Interventions

Dexmedetomidine injection
Midazolam

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Estimated

Primary Completion Date

Jul 31, 2023Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Oct 6, 2022

First Submission Date that Met QC Criteria

Oct 6, 2022

First Posted Date

Oct 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2022

Last Update Posted Date

Oct 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barzah Durrani, Dr Barzah durrani, Sheikh Zayed Medical CollegePrincipal Investigator

Lead Sponsor

Sheikh Zayed Medical CollegeOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
midazola.	Experimental	Inj.midazolam	Drug: Midazolam
Dexnedetomidine	Experimental	inj.dexmedetomidine	Drug: Dexmedetomidine injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine injection	Drug	Inj precedex 200mcg in 1ml given in stat doses	Dexnedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dexmedetomidine is better sedative agent than midazolam in pediatric population		25 minutes

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I and II Age 6 to 12 years Any gender

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

From synopsis approval till completion of sample size

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D008874	Midazolam

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided