The Importance of Anesthesia Method in Fragile Patients

NCT ID: NCT07191769

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-02-28

Brief Summary

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The aim of this study is to comparatively evaluate the effects of different anaesthesia methods (spinal anaesthesia and general anaesthesia) administered to frail elderly patients scheduled for transurethral surgery (e.g. TUR-Prostate or TUR-Bladder) on postoperative morbidity and mortality rates.

Detailed Description

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When planning transurethral surgery in frail patients, optimising the anaesthesia method is critical in minimising perioperative risks. In a 2021 study by Darwish et al. (1), 28,486 TUR-P cases were grouped according to the selected anaesthesia method. The 30-day mortality rate was 0.4% in the neuroaxial anaesthesia (spinal/epidural) group and 0.7% in the general anaesthesia group; the neuroaxial anaesthesia group showed significantly better outcomes in terms of secondary morbidity rates such as mortality and sepsis. However, there are studies in the literature supporting general anaesthesia. A study by Ayoub et al. (4) emphasised that in frail patients, similar morbidity rates can be achieved with general anaesthesia or spinal anaesthesia; spinal anaesthesia may increase the risk of hypotension and bradycardia. Based on these studies, the selection of the appropriate anaesthesia method for transurethral procedures is of critical importance in terms of patient morbidity and mortality rates. This study aims to contribute to clinical guidelines by clarifying which type of anaesthesia is safer in this specific demographic and clinical group. Within the scope of the research, parameters such as complications associated with the anaesthesia method, length of hospital stay, readmission rate, and 30-day mortality are analysed with the aim of determining the most appropriate and safest anaesthesia method for the vulnerable patient group.

Conditions

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Frail Elderly Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing general anaesthesia

Patients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing general anaesthesia.

general anaesthesia

Intervention Type PROCEDURE

Patients undergoing general anaesthesia

Patients undergoing regional anaesthesia

Patients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing regional anaesthesia.

regional anaesthesia

Intervention Type PROCEDURE

Patients undergoing regional anaesthesia

Interventions

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general anaesthesia

Patients undergoing general anaesthesia

Intervention Type PROCEDURE

regional anaesthesia

Patients undergoing regional anaesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elderly patients aged 65 and over
* ASA (American Society of Anaesthesiologists) physical condition classification I-III patients
* meeting the criteria for frailty

Exclusion Criteria

* Non-elective emergency surgeries
* Patients under 65 years of age
* Patients classified as ASA Class IV
* Patients unable to provide informed consent due to cognitive impairment
* Patients who have previously undergone major neurological or cardiac surgery
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dilek Yamac

Role: PRINCIPAL_INVESTIGATOR

Sultan Abdülhamid Han education and research hospital

Central Contacts

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Dilek MD Metin Yamac

Role: CONTACT

05054959792

Dilek M Yamac

Role: CONTACT

05054959792

Other Identifiers

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SBU-ANESTEZİ-DMY-04

Identifier Type: -

Identifier Source: org_study_id

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