Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05323422 |
| Other study ID # |
2021-514-214-38 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 12, 2022 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Kocaeli Derince Education and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
