The Effect of Ketamine on Postoperative Cognitive Dysfunction.

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

Tracking Information

• First Submitted Date: March 23, 2020
• First Posted Date: March 25, 2020
• Last Update Posted Date: December 16, 2020
• Actual Study Start Date: December 10, 2020
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Ketamine on Postoperative Cognitive Dysfunction.
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Prevention
• Condition: 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

Study Arms

• Active Comparator: Ketamine
  Intervention: Drug: Ketamine
• Placebo Comparator: Control
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 24, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2021
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mostafa S Abbas, MD; 01003060187; mostafasamy@aun.edu.eg

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04321746
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Mostafa Samy Abbas, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: December 2020