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The Effect of Ketamine on Postoperative Cognitive Dysfunction.

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ClinicalTrials.gov Identifier: NCT04321746
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 25, 2020
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE December 10, 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
postoperative cognitive dysfunction [ Time Frame: The first few postoperative hours ]
cognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine on Postoperative Cognitive Dysfunction.
Official Title  ICMJE The Effect of Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients Undergoing Orthopaedic Surgery Under Spinal Anaesthesia, a Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Cognitive Dysfunction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Intervention: Drug: Ketamine
  • Placebo Comparator: Control
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mostafa S Abbas, MD 01003060187 mostafasamy@aun.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04321746
Other Study ID Numbers  ICMJE Ketamine
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mostafa Samy Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP