ClinicalTrials.gg
Status unknownNCT05323422Updated Apr 12, 2022

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

An observational study in COVID-19 Pandemic, sponsored by Kocaeli Derince Education and Research Hospital. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Kocaeli Derince Education and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19 Pandemic

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Keywords

  • Covid-19, Ketamine
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 120 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Kocaeli Derince Education and Research Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients with and without covid 19

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
2 Days
Patient registry
Yes

Groups and cohorts

  • Group 1

    COVID-19 positive and pre-induction low-dose intravenous ketamine (0.5 mg/kg) will administering

    Procedure: intravenous Ketamine induction

  • 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

  • Group4

    COVID-19 negative and without intravenous ketamine (0.5 mg/kg)

Interventions

  • Procedureintravenous Ketamine induction

    preoperatively ketamine wll administer in group 1-3

06

What researchers measure

Primary outcomes

  1. evaluation of cognitive function

    Cognitive functions will be evaluated after induction with ketamine in patients with and without covid 19

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05323422
Lead sponsor
Kocaeli Derince Education and Research Hospital
Responsible party
Tahsin Şimşek (medical doctor, Kocaeli Derince Education and Research Hospital) — Principal investigator
First posted
Apr 12, 2022
Start date
Apr 12, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Apr 12, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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