Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries

NCT ID: NCT06498700

Last Updated: 2024-08-19

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-03-15

Brief Summary

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Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.

Detailed Description

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after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.

Conditions

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Subanesthetic Ketamine Dexmedetomidin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ketamine(K)

0.5 mg/kg/h ketamine infusion

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

0.5 mg/kg/h ketamine infusion

dexmedetomidine(D)

0.1 ug/kg/h dexmedetomidine infusion

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

0.1 ug/kg/h dexmedetomidine infusion

Interventions

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ketamine

0.5 mg/kg/h ketamine infusion

Intervention Type DRUG

dexmedetomidine

0.1 ug/kg/h dexmedetomidine infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Aged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.

Exclusion Criteria

Known hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marwa Mohamed Medhat

assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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marwa M Medhat

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

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Faculty of Medicine,Zagazig University

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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440

Identifier Type: -

Identifier Source: org_study_id

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