Patient Group With Alpha Blocker UseNCT06998537
Hemodynamic Effects of Alpha Blockers in Patients With Spinal Anesthesia
An observational study of Patient Group With Alpha Blocker Use, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Group With Alpha Blocker Use
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective urologic surgery under spinal anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İzmir City Hospital
Izmir, Bayraklı, 35000
İzmir City Hospital İzmir City Hospital, +902329550500, izmirsh@saglik.gov.tr
Tuba Kuvvet Yoldas, MD
About this study
Official title: The Effect of Spinal Anaesthesia on Haemodynamic Parameters in Patients Receiving Alpha Blockers
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.
Read the detailed description
Although α-1 adrenergic receptor blockers were initially developed for the treatment of hypertension, they have been widely used in the treatment of benign prostatic hyperplasia (BPH) over the last decade. α-1 adrenergic blockers are frequently used in the treatment of conditions such as benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), which are common in older age groups. α-1 adrenergic receptor blockers contribute to symptom relief by relaxing the smooth muscles of the prostate and bladder neck through inhibition of the sympathetic nervous system . However, blockers that are not receptor selective and cause vascular effects cause an increased risk of hypotension and dizziness when used at therapeutic levels. The hemodynamic effects of α-1 adrenergic blockers are a potential concern, especially in elderly patients. Physiologic changes with age, such as decreased cardiac output, impaired baroreceptor sensitivity, decreased plasma renin levels and renal function, make this patient group more vulnerable to complications related to vasodilation induced by α-blockers. This group of patients also frequently undergoes urological surgery and these procedures are usually performed under spinal anesthesia. Spinal anesthesia may cause significant vasodilatation and thus hemodynamic changes such as hypotension by causing sympathetic nerve blockade. It is predicted that these effects of spinal anesthesia may be increased especially in individuals using α-1 adrenergic blockers. However, there is insufficient data in the literature on the effect of α-1 adrenergic blocker use on intraoperative hemodynamic changes in patients undergoing spinal anesthesia. Existing publications have mostly focused on cases of severe hypotension after 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).
- Conditions
- Patient Group With Alpha Blocker Use
- Keywords
- spinal anesthesia, adrenergic α1-receptor antagonists,, Urologic Surgical Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: α-1 adrenergic blocker users | Not described | |
| Group 2: No α-1 adrenergic blockers. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preop,15 minute,30minute mean arteriyal pressure
Hypotension MBP < 50 mmHg
Measured: During procedure (From the beginning to the end of anesthesia)
Secondary outcomes (1)
Preoperative, 15th and 30th minute heart rate
Bradycardia was defined as HR < 50 bpm
Measured: During procedure (From the beginning to the end of anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Group With Alpha Blocker UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuba Kuvvet Yoldaş, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998537
- Sponsor's protocol ID
- İSH-ANS-TK-01
- Status last verified
- Jul 2025
- First submitted
- 22 May 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Anaesthesia on Haemodynamic Parameters in Patients Receiving Alpha Blockers
- ClinicalTrials.gov ID
- NCT06998537
- Acronym / sponsor ID
- İSH-ANS-TK-01
- Conditions
- Patient Group With Alpha Blocker Use
- Keywords
- spinal anesthesia, adrenergic α1-receptor antagonists,, Urologic Surgical Procedures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although α-1 adrenergic receptor blockers were initially developed for the treatment of hypertension, they have been widely used in the treatment of benign prostatic hyperplasia (BPH) over the last decade. α-1 adrenergic blockers are frequently used in the treatment of conditions such as benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), which are common in older age groups. α-1 adrenergic receptor blockers contribute to symptom relief by relaxing the smooth muscles of the prostate and bladder neck through inhibition of the sympathetic nervous system . However, blockers that are not receptor selective and cause vascular effects cause an increased risk of hypotension and dizziness when used at therapeutic levels. The hemodynamic effects of α-1 adrenergic blockers are a potential concern, especially in elderly patients. Physiologic changes with age, such as decreased cardiac output, impaired baroreceptor sensitivity, decreased plasma renin levels and renal function, make this patient group more vulnerable to complications related to vasodilation induced by α-blockers. This group of patients also frequently undergoes urological surgery and these procedures are usually performed under spinal anesthesia. Spinal anesthesia may cause significant vasodilatation and thus hemodynamic changes such as hypotension by causing sympathetic nerve blockade. It is predicted that these effects of spinal anesthesia may be increased especially in individuals using α-1 adrenergic blockers. However, there is insufficient data in the literature on the effect of α-1 adrenergic blocker use on intraoperative hemodynamic changes in patients undergoing spinal anesthesia. Existing publications have mostly focused on cases of severe hypotension after 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: α-1 adrenergic blocker users | – | – |
| Group 2: No α-1 adrenergic blockers. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective urologic surgery under spinal anesthesia
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preop,15 minute,30minute mean arteriyal pressure
Time frame: During procedure (From the beginning to the end of anesthesia)
Hypotension MBP < 50 mmHg
1 secondary outcome
Preoperative, 15th and 30th minute heart rate
Time frame: During procedure (From the beginning to the end of anesthesia)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Group With Alpha Blocker Use, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Kuvvet Yoldas, MD (+905053428504, tubayoldas2297@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preop,15 minute,30minute mean arteriyal pressure (time frame: During procedure (From the beginning to the end of anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.