Hemodynamic Effects of Alpha Blockers in Patients With Spinal Anesthesia

NCT06998537 | Not Yet Recruiting

• 1 other identifier: İSH-ANS-TK-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

There is frequent use of alpha blockers in elderly patients with urological disorders. Various side effects are encountered due to the use of alpha blockers in the elderly age group. Especially hypotension is one of the common side effects. In addition, urological surgery is frequently performed in this age group. Spinal anesthesia is the most preferred anesthesia method in urological surgery. Spinal anesthesia may cause significant vasodilatation and thus hemodynamic changes such as hypotension by causing sympathetic nerve blockade. It is predicted that spinal anesthesia may increase these effects especially in individuals using α-1 adrenergic blockers. In the literature, serious hypotension has been encountered in individuals using alpha blockers under general anesthesia. The aim of this study was to compare the intraoperative hemodynamic changes in patients undergoing elective urologic surgery under spinal anesthesia between α-1 adrenergic blocker users (Group 1) and non-users(Group 2). Patients were divided into two groups according to drug use: Group 1: α-1 adrenergic blocker users (alfuzosin, doxazosin, terazosin,silodosin, tamsulosin), Group 2: No α-1 adrenergic blockers.

Conditions

Patient Group With Alpha Blocker Use

Keywords

spinal anesthesia; adrenergic α1-receptor antagonists,; Urologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Preop,15 minute,30minute mean arteriyal pressure

  Hypotension MBP \< 50 mmHg

  During procedure (From the beginning to the end of anesthesia)

Secondary Outcomes (1)

• Preoperative, 15th and 30th minute heart rate

  During procedure (From the beginning to the end of anesthesia)

Study Arms (2)

Group 1: α-1 adrenergic blocker users

Group 2: No α-1 adrenergic blockers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective urologic surgery under spinal anesthesia

You may qualify if:

• Patients with American Society of Anesthesiologists (ASA) physical status classification I,II or III over 18 years of age scheduled for elective urologic surgery under spinal anesthesia

You may not qualify if:

• Patients not undergoing spinal anesthesia, non-alpha-blocker vasoactive drug users, patients with cardiac disease, medical/surgical history of brain or spinal cord, neurological or psychiatric disease

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

İzmir City Hospital

Izmir, Bayraklı, 35000, Turkey (Türkiye)

Location

Central Study Contacts

Tuba Kuvvet Yoldas, MD

CONTACT

+905053428504; tubayoldas2297@gmail.com

Mehmet Yoldas, MD

CONTACT

+905304646231; yoldas_2297@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Specialist

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: August 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)