The Effect of Ketamine on Postoperative Cognitive Dysfunction.

Ketamine

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.

Intervention / Treatment

  • 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

Condition or Disease

  • Postoperative Cognitive Dysfunction

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 60 Years and older   (Adult, Older Adult)
    Enrollment: 45 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 10, 2020 ACTUAL
    Primary Completion: Mar 08, 2022 ACTUAL
    Completion Date: Mar 09, 2022 ACTUAL
    Study First Posted: Mar 25, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: May 06, 2022

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    Location

    Asyut, Egypt

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 60
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

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

    More Details

    NCT Number: NCT04321746
    Other IDs: Ketamine
    Study URL: https://clinicaltrials.gov/study/NCT04321746
    Last updated: Sep 29, 2023