Available evidence suggests that there is no significant difference in the incidence of postoperative cognitive dysfunction POCD when general anaesthesia and regional anaesthesia are compared[13, 14]. To the knowledge of the investigators , no studies are examining the effects of ketamine on cognitive outcomes in the setting of spinal anesthesia.
Thus, the purpose of this study was to compare the cognitive status, as assessed by the SPMSQ, of elderly patients undergoing orthopaedic surgery under spinal anaesthesia before and after ketamine administration. The authors hypothesized that patients receiving ketamine would exhibit better cognitive performance.
Full Title of Study: “The Effect of Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients Undergoing Orthopaedic Surgery Under Spinal Anaesthesia, a Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Study Primary Completion Date: October 2020
- Drug: Ketamine
- ketamine will be administered at a dose of 0.3 mg/kg in normal saline at 0.9% (250 mL)
- Other: Placebo
- the control group will receive only normal saline at 0.9%, with the same physical characteristics of the ketamine solution
Arms, Groups and Cohorts
- Active Comparator: Ketamine
- Placebo Comparator: Control
Clinical Trial Outcome Measures
- postoperative cognitive dysfunction
- Time Frame: The first few postoperative hours
- cognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.
Participating in This Clinical Trial
- patients scheduled for orthopaedic surgery under spinal anaesthesia.
- ASA physical status I to II.
- Patients with a history of psychosis, schizophrenia, nephropathy, uncontrolled blood pressure, uncontrolled hepatic disorders, or allergy to ketamine.
- Patients With moderate to severe depression according to Yesavage abbreviated Geriatric Depression Scale,
- Patients presented with postoperative delirium or required medications other than study drugs.
- Ketamine administration is contraindicated.
Gender Eligibility: All
Minimum Age: 60 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Assiut University
- Provider of Information About this Clinical Study
- Principal Investigator: Mostafa Samy Abbas, associate professor of anesthesia – Assiut University
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