Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries
- Conditions
- Subanesthetic Ketamine Dexmedetomidin
- Interventions
- Registration Number
- NCT06498700
- Lead Sponsor
- Zagazig University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 52
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine(K) ketamine 0.5 mg/kg/h ketamine infusion dexmedetomidine(D) dexmedetomidine 0.1 ug/kg/h dexmedetomidine infusion
- Primary Outcome Measures
Name Time Method (PTSD) 6 months To measure the change in PTSD symptom severity using the PTSD Checklist
- Secondary Outcome Measures
Name Time Method VAS (24 hours, 48 hours, and 1 month) postoperative pain
postoperative delirium twice daily for 3 days using the confusion assessment method criteria
Trial Locations
- Locations (1)
Faculty of Medicine,Zagazig University
🇪🇬Zagazig, El Sharkia, Egypt