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History of Changes for Study: NCT05323422
EFFECT OF LOW DOSE INTRAVENOUS KETAMINE GIVEN BEFORE INDUCTION ON POSTOPERATIVE COGNITIVE FUNCTIONS IN PATIENTS WITH COVID-19
Latest version (submitted April 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 11, 2022 None (earliest Version on record)
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Study NCT05323422
Submitted Date:  April 11, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2021-514-214-38
Brief Title: EFFECT OF LOW DOSE INTRAVENOUS KETAMINE GIVEN BEFORE INDUCTION ON POSTOPERATIVE COGNITIVE FUNCTIONS IN PATIENTS WITH COVID-19
Official Title: EFFECT OF LOW DOSE INTRAVENOUS KETAMINE ON POSTOPERATIVE COGNITIVE FUNCTIONS
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Not yet recruiting
Study Start: April 12, 2022
Primary Completion: December 1, 2022 [Anticipated]
Study Completion: January 1, 2023 [Anticipated]
First Submitted: April 11, 2022
First Submitted that
Met QC Criteria:
April 11, 2022
First Posted: April 12, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
April 11, 2022
Last Update Posted: April 12, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Kocaeli Derince Education and Research Hospital
Responsible Party: Principal Investigator
Investigator: Tahsin Şimşek
Official Title: medical doctor
Affiliation: Kocaeli Derince Education and Research Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Postoperative psychomotor dysfunction is called postoperative cognitive dysfunction, and the incidence of postoperative complications is high, especially in elderly patients undergoing major surgery. This complication; It can be attributed to the anesthetic agents used, their doses, and the duration of the surgery. Although SARS-CoV-2 virus causes an infection called Covid-19 that mainly affects the respiratory tract, data have been obtained that it can enter the nasal mucosa, reach the central nervous system via olfactory fibers or hematogenous way, and infect endothelial cells and neurons. The immune system is activated due to endothelial cell damage, vascular permeability increases, and the risk of thrombosis occurs. Cerebral hypoperfusion promotes Lewy body development, especially by increasing amyloid plaque formation and inducing serine phosphorylation. The formation of these plaques, which are responsible for the development of Alzheimer's and Dementia, suggests that Covid-19 may have long-term neurological complications. In our study, we included patients who were scheduled for cholecystectomy, who had and did not have covid-19 infection. Covid-19 infection (Group 1), no previous (Group 2), COVID-19 and pre-induction low-dose intravenous ketamine (0.5 mg/kg) administered (Group 3), non-covid-19 and pre-induction low-dose intravenous ketamine We aimed to evaluate and compare postoperative cognitive functions in patients (Group 4) administered (0.5 mg/kg). Ketamine is a sedative, hypnotic and analgesic agent and has an effective role in balanced anesthesia. In addition, its use reduces the need for the use of other anesthetic agents. The use of ketamine in normal doses causes a decrease in brain and cognitive functions; The use of sub-anesthetic doses before induction has positive effects on recovery and cognitive functions. Depth of anesthesia with bispectral index continuously before and throughout the operation; The lowest and highest values were recorded by regional cerebral oximetry (rSO2) measurement. Cognitive tests were performed 1 day before the operation, at the 12th hour and 30 days after the operation. MMT (mini mental test), Verbal Fluency Test (verbal fluency test), Clock Drawing Test (clock drawing test) Aldrete recovery scores were evaluated at the 2nd and 5th minutes after extubation. The study included 160 patients, 35-55 young and middle-aged, ASA I and II. Patients who underwent emergency surgery, had malignancy, and had a known chronic disease were excluded from the study.
Detailed Description: Postoperative psychomotor dysfunction is called postoperative cognitive dysfunction, and the incidence of postoperative complications is high, especially in elderly patients undergoing major surgery. This complication; It can be attributed to the anesthetic agents used, their doses, and the duration of the surgery. Although SARS-CoV-2 virus causes an infection called Covid-19 that mainly affects the respiratory tract, data have been obtained that it can enter the nasal mucosa, reach the central nervous system via olfactory fibers or hematogenous way, and infect endothelial cells and neurons. The immune system is activated due to endothelial cell damage, vascular permeability increases, and the risk of thrombosis occurs. Cerebral hypoperfusion promotes Lewy body development, especially by increasing amyloid plaque formation and inducing serine phosphorylation. The formation of these plaques, which are responsible for the development of Alzheimer's and Dementia, suggests that Covid-19 may have long-term neurological complications. In our study, we included patients who were scheduled for cholecystectomy, who had and did not have covid-19 infection. Covid-19 infection (Group 1), no previous (Group 2), COVID-19 and pre-induction low-dose intravenous ketamine (0.5 mg/kg) administered (Group 3), non-covid-19 and pre-induction low-dose intravenous ketamine We aimed to evaluate and compare postoperative cognitive functions in patients (Group 4) administered (0.5 mg/kg). Ketamine is a sedative, hypnotic and analgesic agent and has an effective role in balanced anesthesia. In addition, its use reduces the need for the use of other anesthetic agents. The use of ketamine in normal doses causes a decrease in brain and cognitive functions; The use of sub-anesthetic doses before induction has positive effects on recovery and cognitive functions. Depth of anesthesia with bispectral index continuously before and throughout the operation; The lowest and highest values were recorded by regional cerebral oximetry (rSO2) measurement. Cognitive tests were performed 1 day before the operation, at the 12th hour and 30 days after the operation. MMT (mini mental test), Verbal Fluency Test (verbal fluency test), Clock Drawing Test (clock drawing test) Aldrete recovery scores were evaluated at the 2nd and 5th minutes after extubation. The study included 160 patients, 35-55 young and middle-aged, ASA I and II. Patients who underwent emergency surgery, had malignancy, and had a known chronic disease were excluded from the study.
Open or close this module Conditions
Conditions: COVID-19 Pandemic
Keywords: Covid-19, Ketamine
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Other
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 120 [Anticipated]
Number of Groups/Cohorts 4
Target Follow-Up Duration: 2 Days
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Group 1
COVID-19 positive and pre-induction low-dose intravenous ketamine (0.5 mg/kg) will administering
Procedure: intravenous Ketamine induction
preoperatively ketamine wll administer in group 1-3
Group 2
COVID-19 positive and without intravenous ketamine (0.5 mg/kg)
Group -3
COVID-19 negative and pre-induction low-dose intravenous ketamine (0.5 mg/kg) will administering
Procedure: intravenous Ketamine induction
preoperatively ketamine wll administer in group 1-3
Group4
COVID-19 negative and without intravenous ketamine (0.5 mg/kg)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. evaluation of cognitive function
[ Time Frame: 6 months ]

Cognitive functions will be evaluated after induction with ketamine in patients with and without covid 19
Open or close this module Eligibility
Study Population: patients with and without covid 19
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers:
Criteria:

Inclusion Criteria:

  • Patients aged 35-55 years ASA 1, 2 group Patients scheduled for cholecystectomy

Exclusion criteria:

Patient's refusal to participate in the study Those with malignancy Patients scheduled for emergency surgery

Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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