NCT06597812

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 12, 2024

Last Update Submit

September 14, 2024

Conditions

Cognitive Dysfunction, Cognitive DisorderDelirium - Postoperative

Keywords

deliriumMini-Coganaesthesia

Outcome Measures

Primary Outcomes (1)

  • Group P-S

    Incidence of postoperative delirium in patients receiving sevoflurane or propofol-based total intravenous anesthesia

    postoperative 0 1st 2nd hours

Study Arms (2)

group s

Patients receiving sevoflurane

Procedure: Sevoflurane

Group p

Patients receiving propofol-based total intravenous anesthesia

Procedure: Sevoflurane

Interventions

SevofluranePROCEDURE

Depending on the anesthesia maintenance protocol, total intravenous anesthesia (TIVA) or sevoflurane anesthesia, patients were divided into group T (TIVA) and group S (sevoflurane).

Group pgroup s

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 60 years of age who are scheduled for laparoscopic cholecystectomy

You may qualify if:

  • There was a correlation between the incidence of delirium after the age of 60(10).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Hospital

Amasya, Amasya, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 35443735BACKGROUND

  • 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.

    PMID: 35441485BACKGROUND

  • 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.

    PMID: 29190460BACKGROUND

  • Duran HT, Kizilkaya M, Aydinli A, Osmantevfik S, Tastan S, Kilinc OO, Pirhan Y. The effect of two different modes of anaesthesia maintenance on postoperative delirium in elderly patient with low preoperative mini-cog score. BMC Anesthesiol. 2024 Oct 1;24(1):350. doi: 10.1186/s12871-024-02735-y.

    PMID: 39354373DERIVED

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionEmergence DeliriumDelirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of Anaesthesiology and reanimation department

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

TU(1)