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Enrolling by Invitation

NCT Number: NCT06498700

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

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

Enrolling by Invitation

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Key information

Conditions

Subanesthetic Ketamine Dexmedetomidin

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine,Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

0.5 mg/kg/h ketamine infusion

Dexmedetomidine

Drug

0.1 ug/kg/h dexmedetomidine infusion

Primary outcomes

  1. (PTSD)

    Time frame: 6 months

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

Secondary outcomes

  1. VAS

    Time frame: (24 hours, 48 hours, and 1 month)

    postoperative pain

  2. postoperative delirium

    Time frame: twice daily for 3 days

    using the confusion assessment method criteria

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.