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NCT Number: NCT04321746

The Effect of Ketamine on Postoperative Cognitive Dysfunction.

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ketamine

Drug

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

Placebo

Other

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

Primary outcomes

  1. postoperative cognitive dysfunction

    Time frame: first postoperative day

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2020
Registry last updated
May 10, 2022

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.

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