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The Effect of Ketamine on Postoperative Cognitive Dysfunction.

The Effect of Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients Undergoing Orthopaedic Surgery Under Spinal Anaesthesia, a Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04321746
Enrollment
45
Registered
2020-03-25
Start date
2020-12-10
Completion date
2022-03-09
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Brief summary

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.

Interventions

DRUGKetamine

ketamine will be administered at a dose of 0.3 mg/kg in normal saline at 0.9% (250 mL)

OTHERPlacebo

the control group will receive only normal saline at 0.9%, with the same physical characteristics of the ketamine solution

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients scheduled for orthopaedic surgery under spinal anaesthesia. * ASA physical status I to II.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative cognitive dysfunctionfirst postoperative daycognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026