Comparison Between Effect of Vitamin D Versus Dexmedetomidine in Patients with Head Trauma Using Interleukin 6

NCT ID: NCT06565338

Last Updated: 2024-11-04

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

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-25

Study Completion Date

2024-02-05

Brief Summary

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in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker

Detailed Description

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patients with moderate head trauma (GCS 8-12) within first 24 hours were randomly divided into 2 groups, first group received 100,000 IU of vitamin D was given IM \& the other group received dexmedetomidine 0.4 mic/kg as loading dose then 0.25 mic/kg/hr as maintainence dose for 5 days detecting APATCHE at admission and following up of vital signs (HR \& NIBP) \& investigations (CBC \& RFT\& ABG \& ESR\& CRP \& IL-6) \& GCS and GOS for 5 days.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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group A

dexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days

Dexmedetomidine

Intervention Type DRUG

drug

group B

vitamin D 100.000 IU given IM once

Vitamin D3

Intervention Type DRUG

drug

Interventions

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Dexmedetomidine

drug

Intervention Type DRUG

Vitamin D3

drug

Intervention Type DRUG

Other Intervention Names

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precedex depovit - decaprino

Eligibility Criteria

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Inclusion Criteria

* Both Gender.
* Age (18-50)
* GCS (8-12)
* Pt with traumatic brain insult who not indicated surgical intervention

Exclusion Criteria

* Prior severe disability.
* Isolated brain system lesions.
* History of underlying neurologic, metabolic or psychiatric disorders.
* Alcohol or drug abuse.
* Pregnancy.
* Patients with intracranial hemorrhage who indicated surgical evacuation.
* Multisystem life-threatening trauma.
* GCS \> 12 \& \<8.
* Vitamin d deficiency.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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asmaa elhelw

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed ezz

Role: STUDY_CHAIR

Minia University

Locations

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Asmaa

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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403

Identifier Type: -

Identifier Source: org_study_id

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