Back to resultsThe Effect of Ketamine on Postoperative Cognitive Dysfunction.
Primary Purpose
Postoperative Cognitive Dysfunction
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Cognitive Dysfunction
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.
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ketamine
Control
Arm Description
Outcomes
Primary Outcome Measures
postoperative cognitive dysfunction
cognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04321746
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
ketamine will be administered at a dose of 0.3 mg/kg in normal saline at 0.9% (250 mL)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
the control group will receive only normal saline at 0.9%, with the same physical characteristics of the ketamine solution
Primary Outcome Measure Information:
Title
postoperative cognitive dysfunction
Description
cognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.
Time Frame
first postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Ketamine on Postoperative Cognitive Dysfunction.
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