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NCT Number: NCT07191769

The Importance of Anesthesia Method in Fragile Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General anaesthesia

Procedure

Patients undergoing general anaesthesia

regional anaesthesia

Procedure

Patients undergoing regional anaesthesia

Primary outcomes

  1. Postoperative morbidity

    Time frame: 30-day postoperative morbidity

    Morbidity rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.

  2. Postoperative mortality

    Time frame: 30-day postoperative mortality

    Mortality rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.

Secondary outcomes

  1. intraoperative complications,

    Time frame: perioperative period

    In the study, complications that develop during surgery (arrhythmia etc.), whether the surgical time differs between the two groups, and the length of hospital stay will be recorded.

  2. Duration of surgery

    Time frame: Until the end of the surgery

    The surgical durations of patients in both groups will be recorded in the study.

  3. Length of hospital stay

    Time frame: first week after surgery

    The length of time the patient stays in hospital for the operation will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek M Yamac

CONTACT

[email protected]

05054959792

Dilek MD Metin Yamac

CONTACT

[email protected]

05054959792

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

The Effect of the Selected Anaesthesia Method on Morbidity and Mortality in Frail Patients Scheduled for Transurethral Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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