EFFECT OF LOW DOSE INTRAVENOUS KETAMINE GIVEN BEFORE INDUCTION ON POSTOPERATIVE COGNITIVE FUNCTIONS IN PATIENTS WITH COVID-19

EFFECT OF LOW DOSE INTRAVENOUS KETAMINE ON POSTOPERATIVE COGNITIVE FUNCTIONS

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Procedure: intravenous Ketamine induction

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with and without covid 19

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of cognitive function	Cognitive functions will be evaluated after induction with ketamine in patients with and without covid 19	6 months

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 12, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19, Ketamine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 2021-514-214-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No