The Importance of Anesthesia Method in Fragile Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elderly patients aged 65 and over

ASA (American Society of Anaesthesiologists) physical condition classification I-III patients

meeting the criteria for frailty

Disqualifiers

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

Trial population

Patients aged 65 years and older who are scheduled for transurethral surgery (such as TUR-P or TUR-M), meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in the study. A validated frailty score (FRAIL Survey) will be used for frailty assessment.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • general anaesthesia

    Procedure/Surgery

    Patients undergoing general anaesthesia

  • regional anaesthesia

    Procedure/Surgery

    Patients undergoing regional anaesthesia

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Patients undergoing general anaesthesia1 intervention
Group B: Patients undergoing regional anaesthesia1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30-day postoperative morbidity
2

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.

Time frame
30-day postoperative mortality

Secondary outcomes

1

intraoperative complications,

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.

Time frame
perioperative period
2

Duration of surgery

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

Time frame
Until the end of the surgery
3

Length of hospital stay

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

Time frame
first week after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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