General anaesthesia
ProcedurePatients undergoing general anaesthesia
NCT Number: NCT07191769
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients undergoing general anaesthesia
Patients undergoing regional anaesthesia
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.
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.
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.
Time frame: Until the end of the surgery
The surgical durations of patients in both groups will be recorded in the study.
Time frame: first week after surgery
The length of time the patient stays in hospital for the operation will be recorded.
Contact information is provided by the study sponsor or research team.
Dilek M Yamac
CONTACT
Dilek MD Metin Yamac
CONTACT
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Other
The Effect of the Selected Anaesthesia Method on Morbidity and Mortality in Frail Patients Scheduled for Transurethral Surgery
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.
Published trials that share one or more normalized conditions with this study.
NCT07561021
Cardiovascular Diseases, Frail Elderly Syndrome
View Trial DetailsNCT07182292
Frail Elderly Syndrome, Frailty
View Trial DetailsNCT06663150
Frail Elderly Syndrome, Frailty
View Trial DetailsNCT03964363
Frail Elderly Syndrome, Frailty
München, Bavaria, Germany
View Trial Details