The Effect of Ketamine on Postoperative Cognitive Dysfunction.

NCT04321746 | Completed Phase 4

• 1 other identifier: Ketamine
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Drug: Ketamine

Control

PLACEBO COMPARATOR

Other: Placebo

Interventions

Ketamine DRUG

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

Ketamine

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: December 10, 2020
• Primary Completion: March 8, 2022
• Study Completion: March 9, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)