NCT06498700

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

July 7, 2024

Last Update Submit

August 15, 2024

Conditions

Subanesthetic Ketamine Dexmedetomidin

Keywords

Ketamine, Dexmedetomidine ,Post-traumatic Stress Disorder , traumatic Brain surgeries

Outcome Measures

Primary Outcomes (1)

  • (PTSD)

    To measure the change in PTSD symptom severity using the PTSD Checklist

    6 months

Secondary Outcomes (2)

  • VAS

    (24 hours, 48 hours, and 1 month)

  • postoperative delirium

    twice daily for 3 days

Study Arms (2)

Ketamine(K)

EXPERIMENTAL

0.5 mg/kg/h ketamine infusion

Drug: ketamine

dexmedetomidine(D)

EXPERIMENTAL

0.1 ug/kg/h dexmedetomidine infusion

Drug: dexmedetomidine

Interventions

ketamineDRUG

0.5 mg/kg/h ketamine infusion

Ketamine(K)
dexmedetomidineDRUG

0.1 ug/kg/h dexmedetomidine infusion

dexmedetomidine(D)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Interventions

KetamineDexmedetomidine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • marwa M Medhat

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

First Submitted

July 7, 2024

First Posted

July 12, 2024

Study Start

July 15, 2024

Primary Completion

December 15, 2024

Study Completion

March 15, 2025

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)