- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06597812
The Effect of Two Different Modes of Anaesthesia Mainantance on Postoperative Delirium
September 14, 2024 updated by: Harun Tolga Duran, Amasya University
The Effect of Two Different Modes of Anaesthesia Mainantance on Postoperative Delirium in Elderly Patient with Low Preoperative Mini-cog Score
In this study, the cognitive status of the patients in the preoperative period was taken into consideration and the development of delirium after the surgery was investigated.
There is no harm to the patient.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The patients were preoperatively assessed for American Society of Anesthesiologists (ASA) risk by an anesthetist and age, sex and comorbidities were recorded.
The Mini-cog test was applied as a cognitive screening test by the anesthesiologist in the preoperative period and the test score was recorded.
Three-word memory test, clock drawing, and visual function test was performed to evaluate the patient's cognitive functions.
In this test, patients were asked to memorize three words such as umbrella, sunshine, and chair at the beginning of the test.
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amasya, Turkey
- Amasya University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients over 60 years of age who are scheduled for laparoscopic cholecystectomy
Description
Inclusion Criteria:
- There was a correlation between the incidence of delirium after the age of 60(10).
Exclusion Criteria:
- Patients' age< 60 years,
- Patients undergoing emergency cholecystectomy or did not have preoperative Mini-Cog assessment,
- With a history of cerebrovaskuler insult that was thought to have an effect on postoperative delirium ,
- Patients with difficulty in cooperation ,
- Patients with hemodynamic instability(arterial blood pressure above 160/90 mmHg and below 90/60 mmHg and patients with pulse rate below 50/min and above 100/min) ,
- Patients with previously diagnosed dementia, and those who had surgical procedures lasting more than 2 hours were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group s
Patients receiving sevoflurane
|
Depending on the anesthesia maintenance protocol, total intravenous anesthesia (TIVA) or sevoflurane anesthesia, patients were divided into group T (TIVA) and group S (sevoflurane).
|
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Group p
Patients receiving propofol-based total intravenous anesthesia
|
Depending on the anesthesia maintenance protocol, total intravenous anesthesia (TIVA) or sevoflurane anesthesia, patients were divided into group T (TIVA) and group S (sevoflurane).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group P-S
Time Frame: postoperative 0 1st 2nd hours
|
Incidence of postoperative delirium in patients receiving sevoflurane or propofol-based total intravenous anesthesia
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postoperative 0 1st 2nd hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fiamanya S, Ma S, Yates DRA. The association between preoperative Mini-Cog(c) score and postoperative delirium (POD): a retrospective cohort study. Perioper Med (Lond). 2022 Apr 21;11(1):16. doi: 10.1186/s13741-022-00249-0.
- Jing GW, Xie Q, Tong J, Liu LZ, Jiang X, Si L. Early Intervention of Perioperative Delirium in Older Patients (>60 years) with Hip Fracture: A Randomized Controlled Study. Orthop Surg. 2022 May;14(5):885-891. doi: 10.1111/os.13244. Epub 2022 Apr 19.
- Racine AM, Fong TG, Gou Y, Travison TG, Tommet D, Erickson K, Jones RN, Dickerson BC, Metzger E, Marcantonio ER, Schmitt EM, Inouye SK. Clinical outcomes in older surgical patients with mild cognitive impairment. Alzheimers Dement. 2018 May;14(5):590-600. doi: 10.1016/j.jalz.2017.10.010. Epub 2017 Nov 27.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
October 1, 2023
Study Completion (Actual)
November 1, 2023
Study Registration Dates
First Submitted
September 12, 2024
First Submitted That Met QC Criteria
September 14, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 14, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Cognitive Dysfunction
- Emergence Delirium
- Cognition Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Anesthetics, Inhalation
- Sevoflurane
Other Study ID Numbers
- 2023/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I approve the usability in multicenter studies in the study plan population
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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