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The Importance of Anesthesia Method in Fragile Patients

S

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status

Not yet enrolling

Conditions

Frail Elderly Syndrome

Treatments

Procedure: regional anaesthesia
Procedure: general anaesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT07191769
SBU-ANESTEZİ-DMY-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

Patients undergoing general anaesthesia
Description:
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.
Treatment:
Procedure: general anaesthesia
Patients undergoing regional anaesthesia
Description:
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.
Treatment:
Procedure: regional anaesthesia

Trial contacts and locations

0

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Central trial contact

Dilek M Yamac; Dilek MD Metin Yamac

Data sourced from clinicaltrials.gov

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