The Effect of Ketamine on Postoperative Cognitive Dysfunction.

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321746
• Other study ID #: Ketamine
• Status: Completed
• Phase: Phase 4
• Start date: December 10, 2020
• Est. completion date: March 9, 2022

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 9, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative cognitive dysfunction	cognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.	first postoperative day