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Enrolling by invitation NCT06498700

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

No phase Interventional Subanesthetic Ketamine Dexmedetomidin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ketamine, dexmedetomidine.
Who it may be relevant to
Registry conditions: Subanesthetic Ketamine Dexmedetomidin. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

  • Drug ketamine
    0.5 mg/kg/h ketamine infusion
  • Drug dexmedetomidine
    0.1 ug/kg/h dexmedetomidine infusion

Primary outcome measures

  • (PTSD) [Time frame: 6 months]
Secondary outcome measures (2)
  • VAS [Time frame: (24 hours, 48 hours, and 1 month)]
  • postoperative delirium [Time frame: twice daily for 3 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine,Zagazig University — Zagazig

Identifiers

NCT: NCT06498700 · 440

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗