The Importance of Anesthesia Method in Fragile Patients

NCT07191769 | Not Yet Recruiting

• 1 other identifier: SBU-ANESTEZİ-DMY-04
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Frail Elderly Syndrome

Keywords

frail patient; general anaesthesia; regional anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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.

  30-day postoperative morbidity

• 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.

  30-day postoperative mortality

Secondary Outcomes (3)

• intraoperative complications,

  perioperative period

• Duration of surgery

  Until the end of the surgery

• Length of hospital stay

  first week after surgery

Study Arms (2)

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.

Procedure: 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.

Procedure: regional anaesthesia

Interventions

general anaesthesia PROCEDURE

Patients undergoing general anaesthesia

Patients undergoing general anaesthesia

regional anaesthesia PROCEDURE

Patients undergoing regional anaesthesia

Patients undergoing regional anaesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

MeSH Terms

Interventions

Anesthesia, General; Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Dilek Yamac

  Sultan Abdülhamid Han education and research hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek MD Metin Yamac

CONTACT

05054959792; ddilekmetin@hotmail.com

Dilek M Yamac

CONTACT

05054959792; ddilekmetin@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 25, 2025
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share