Benign Prostatic HyperplasiaNCT07734233
Spinal Versus General Anesthesia on Coagulation and Fibrinolysis During Transurethral Resection of the Prostate
A study testing Spinal Anesthesia (bupivacaine) and General Anaesthesia in people with Benign Prostatic Hyperplasia and Transurethral Resection of the Prostate (TURP), run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized clinical trial aims to compare the effects of spinal and general anesthesia on perioperative coagulation and fibrinolysis in patients undergoing elective transurethral resection of the prostate (TURP). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate (TURP)
- What is being tested?
- Spinal Anesthesia (bupivacaine) and General Anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients
- Age ≥18 years
- Scheduled for elective bipolar transurethral resection of the prostate
- ASA physical status I-II
- Ability to provide written informed consent
Who cannot join
- History of deep vein thrombosis or pulmonary embolism
- Known inherited or acquired coagulation disorder
- Severe hepatic insufficiency
- Severe renal insufficiency
- Use of anticoagulants, antiplatelet drugs, or NSAIDs within 10 days before surgery
- Platelet count <100 × 10⁹/L
Show all 12Show fewer
- INR >1.5
- aPTT >47 seconds
- Contraindications to spinal anesthesia
- Prostate malignancy
- ASA physical status III or higher
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultangazi Haseki Training and Research Hospital
Istanbul, Istanbul, 34265
About this study
Official title: Effects of Spinal Versus General Anesthesia on Coagulation and Fibrinolysis in Patients Undergoing Transurethral Resection of the Prostate: A Prospective Randomized Study
This prospective randomized clinical trial aims to compare the effects of spinal and general anesthesia on perioperative coagulation and fibrinolysis in patients undergoing elective transurethral resection of the prostate (TURP). Blood samples are collected before surgery and at 1 and 24 hours postoperatively to evaluate coagulation and fibrinolytic parameters. The study also assesses perioperative hemodynamic events and postoperative complications.
Read the detailed description
Transurethral resection of the prostate (TURP) is one of the most commonly performed surgical procedures for benign prostatic hyperplasia. Surgical trauma activates both coagulation and fibrinolytic pathways, and prostate tissue possesses unique fibrinolytic properties due to its high concentration of plasminogen activators. The anesthetic technique may modify perioperative hemostasis through its effects on the neuroendocrine stress response.
The purpose of this prospective randomized study is to compare spinal anesthesia and general anesthesia with respect to perioperative and early postoperative changes in coagulation and fibrinolysis. Venous blood samples are obtained before surgery and at 1 and 24 hours after surgery for measurement of prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen concentration, and D-dimer levels.
- Being tested
- Spinal Anesthesia (bupivacaine), General Anaesthesia
- Keywords
- Transurethral Resection of the Prostate (TURP), General Anesthesia, Spinal Anesthesia, Coagulation, Fibrinolysis, Fibrinogen, D-dimer, Hemostasis
- Medical subject headings
- Prostatic Hyperplasia, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia (bupivacaine)Procedure or surgery
Spinal anesthesia was performed at the L4-L5 interspace using 12.5 mg of hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP). Standard intraoperative monitoring and perioperative management were applied.
General AnaesthesiaProcedure or surgery
General anesthesia was induced with intravenous propofol, fentanyl, and rocuronium, and maintained with sevoflurane. Standard intraoperative monitoring and perioperative management were applied during elective bipolar transurethral resection of the prostate (TURP).
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | Experimental | Participants received spinal anesthesia with hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP). Receives: Procedure: Spinal Anesthesia (bupivacaine) |
| general anesthesia | Active comparator | Participants received standardized general anesthesia for elective bipolar transurethral resection of the prostate (TURP). Receives: Procedure: General Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments
Prothrombin time (PT) will be measured to evaluate perioperative changes in the extrinsic coagulation pathway. Unit of Measure: Seconds
Measured: Baseline, 1 hour after surgery, and 24 hours after surgery
Change in Activated Partial Thromboplastin Time (aPTT) from Baseline to Postoperative Assessments
Activated partial thromboplastin time (aPTT) will be measured to evaluate changes in the intrinsic coagulation pathway. Units of measure: seconds
Measured: Baseline, 1 hour after surgery, and 24 hours after surgery
Change in International Normalized Ratio (INR) from Baseline to Postoperative Assessments
INR will be measured as a standardized indicator of coagulation status. Unit of Measure: Ratio
Measured: Baseline, 1 hour after surgery, and 24 hours after surgery
Change in Fibrinogen Concentration from Baseline to Postoperative Assessments
Plasma fibrinogen concentration will be measured to evaluate changes in coagulation activity. Unit of Measure: mg/dL
Measured: Baseline, 1 hour after surgery, and 24 hours after surgery
Change in D-dimer Concentration from Baseline to Postoperative Assessments
Plasma D-dimer concentration will be measured to evaluate perioperative fibrinolytic activation. Unit of Measure: mg/L
Measured: Baseline, 1 hour after surgery, and 24 hours after surgery
Secondary outcomes (1)
Incidence of adverse events
- Hypotension
- Hypertension
- Bradycardia
- Tachycardia
- Cardiac arrhythmia
- Hypoxemia
Measured: From induction of anesthesia until completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start10 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either spinal anesthesia or general anesthesia, and outcomes were compared between the two parallel groups.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Uzman, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734233
- Sponsor's protocol ID
- 18-2024
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available.
Publications
Smyth R, Cheng D, Asokumar B, Chung F. Coagulopathies in patients after transurethral resection of the prostate: spinal versus general anesthesia. Anesth Analg. 1995 Oct;81(4):680-5. doi: 10.1097/00000539-199510000-00004.
PubMed 7573993
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spinal Versus General Anesthesia on Coagulation and Fibrinolysis in Patients Undergoing Transurethral Resection of the Prostate: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07734233
- Acronym / sponsor ID
- 18-2024
- Keywords
- Transurethral Resection of the Prostate (TURP), General Anesthesia, Spinal Anesthesia, Coagulation, Fibrinolysis, Fibrinogen, D-dimer, Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 29 Jul 2026 (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.
This prospective randomized clinical trial aims to compare the effects of spinal and general anesthesia on perioperative coagulation and fibrinolysis in patients undergoing elective transurethral resection of the prostate (TURP). Blood samples are collected before surgery and at 1 and 24 hours postoperatively to evaluate coagulation and fibrinolytic parameters. The study also assesses perioperative hemodynamic events and postoperative complications.
Detailed description
Transurethral resection of the prostate (TURP) is one of the most commonly performed surgical procedures for benign prostatic hyperplasia. Surgical trauma activates both coagulation and fibrinolytic pathways, and prostate tissue possesses unique fibrinolytic properties due to its high concentration of plasminogen activators. The anesthetic technique may modify perioperative hemostasis through its effects on the neuroendocrine stress response.
The purpose of this prospective randomized study is to compare spinal anesthesia and general anesthesia with respect to perioperative and early postoperative changes in coagulation and fibrinolysis. Venous blood samples are obtained before surgery and at 1 and 24 hours after surgery for measurement of prothrombin time, activated partial thromboplastin time, international normalized ratio, fibrinogen concentration, and D-dimer levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either spinal anesthesia or general anesthesia, and outcomes were compared between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | Experimental | Procedure: Spinal Anesthesia (bupivacaine)Participants received spinal anesthesia with hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP). |
| general anesthesia | Active comparator | Procedure: General AnaesthesiaParticipants received standardized general anesthesia for elective bipolar transurethral resection of the prostate (TURP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients
- Age ≥18 years
- Scheduled for elective bipolar transurethral resection of the prostate
- ASA physical status I-II
- Ability to provide written informed consent
Key exclusion criteria (12 listed)
- History of deep vein thrombosis or pulmonary embolism
- Known inherited or acquired coagulation disorder
- Severe hepatic insufficiency
- Severe renal insufficiency
- Use of anticoagulants, antiplatelet drugs, or NSAIDs within 10 days before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Anesthesia (bupivacaine)Spinal anesthesia was performed at the L4-L5 interspace using 12.5 mg of hyperbaric bupivacaine for elective bipolar transurethral resection of the prostate (TURP). Standard intraoperative monitoring and perioperative management were applied. | Procedure or surgery | spinal anesthesia |
| General AnaesthesiaGeneral anesthesia was induced with intravenous propofol, fentanyl, and rocuronium, and maintained with sevoflurane. Standard intraoperative monitoring and perioperative management were applied during elective bipolar transurethral resection of the prostate (TURP). | Procedure or surgery | general anesthesia |
Primary outcome
Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments
Time frame: Baseline, 1 hour after surgery, and 24 hours after surgery
Prothrombin time (PT) will be measured to evaluate perioperative changes in the extrinsic coagulation pathway. Unit of Measure: Seconds
Change in Activated Partial Thromboplastin Time (aPTT) from Baseline to Postoperative Assessments
Time frame: Baseline, 1 hour after surgery, and 24 hours after surgery
Activated partial thromboplastin time (aPTT) will be measured to evaluate changes in the intrinsic coagulation pathway. Units of measure: seconds
Change in International Normalized Ratio (INR) from Baseline to Postoperative Assessments
Time frame: Baseline, 1 hour after surgery, and 24 hours after surgery
INR will be measured as a standardized indicator of coagulation status. Unit of Measure: Ratio
Change in Fibrinogen Concentration from Baseline to Postoperative Assessments
Time frame: Baseline, 1 hour after surgery, and 24 hours after surgery
Plasma fibrinogen concentration will be measured to evaluate changes in coagulation activity. Unit of Measure: mg/dL
Change in D-dimer Concentration from Baseline to Postoperative Assessments
Time frame: Baseline, 1 hour after surgery, and 24 hours after surgery
Plasma D-dimer concentration will be measured to evaluate perioperative fibrinolytic activation. Unit of Measure: mg/L
1 secondary outcome
Incidence of adverse events
Time frame: From induction of anesthesia until completion of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 7573993Smyth R, Cheng D, Asokumar B, Chung F. Coagulopathies in patients after transurethral resection of the prostate: spinal versus general anesthesia. Anesth Analg. 1995 Oct;81(4):680-5. doi: 10.1097/00000539-199510000-00004.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia (bupivacaine) and General Anaesthesia in people with Benign Prostatic Hyperplasia and Transurethral Resection of the Prostate (TURP), run by Haseki Training and Research 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prothrombin Time (PT) from Baseline to Postoperative Assessments (time frame: Baseline, 1 hour after surgery, and 24 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734233, which also lists 1 linked publication.
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 29 Jul 2026.