The Effect of Ketamine on Postoperative Cognitive Dysfunction.

NCT ID: NCT04321746

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2022-03-09

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.

Conditions

Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Ketamine

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

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

Control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Ketamine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Samy Abbas

associate professor of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

Ketamine

Identifier Type: -

Identifier Source: org_study_id