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Not yet recruiting NCT07191769

The Importance of Anesthesia Method in Fragile Patients

Observational Frail Elderly Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: general anaesthesia, regional anaesthesia.
Who it may be relevant to
Registry conditions: Frail Elderly Syndrome. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Procedure general anaesthesia
    Patients undergoing general anaesthesia
  • Procedure regional anaesthesia
    Patients undergoing regional anaesthesia

Primary outcome measures

  • Postoperative morbidity [Time frame: 30-day postoperative morbidity]
  • Postoperative mortality [Time frame: 30-day postoperative mortality]
Secondary outcome measures (3)
  • intraoperative complications, [Time frame: perioperative period]
  • Duration of surgery [Time frame: Until the end of the surgery]
  • Length of hospital stay [Time frame: first week after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07191769 · SBU-ANESTEZİ-DMY-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗