HypotensionNCT07551219
Effects of Ondansetron on Hemodynamic Changes After Spinal Anesthesia in Geriatric Urologic Surgery
An observational study of Hypotension and Bradycardia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia is frequently used in urologic surgery in geriatric patients; however, it may cause significant hemodynamic changes such as hypotension and bradycardia. These changes can be more pronounced in elderly patients due to age-related physiological alterations. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension, Bradycardia, Hypotension During Surgery
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2024to 18 Apr 2025
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of geriatric patients aged 65 years and older undergoing elective urologic surgery under spinal anesthesia. Patients were managed according to routine clinical practice, with or without prophylactic ondansetron administration. Perioperative hemodynamic parameters, including blood pressure and heart rate, were prospectively recorded during the intraoperative period.
Who may be able to join
- Patients aged 65 years and older Patients scheduled for elective urologic surgery under spinal anesthesia American Society of Anesthesiologists (ASA) physical status I-III Patients who received routine perioperative management, with or without ondansetron administration Patients who provided written informed consent
Who cannot join
- Refusal or contraindication to spinal anesthesia Known hypersensitivity or contraindication to ondansetron Preexisting severe cardiac conduction abnormalities (e.g., high-grade atrioventricular block, sick sinus syndrome) Baseline bradycardia (heart rate < 50 beats per minute) Chronic use of medications significantly affecting heart rate or blood pressure (e.g., beta-blockers, calcium channel blockers, antiarrhythmic drugs) Emergency surgery Incomplete perioperative hemodynamic data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ondansetron on Hemodynamic Changes Induced by Spinal Anesthesia in Geriatric Urologic Surgery Patients
Spinal anesthesia is frequently used in urologic surgery in geriatric patients; however, it may cause significant hemodynamic changes such as hypotension and bradycardia. These changes can be more pronounced in elderly patients due to age-related physiological alterations. Ondansetron, a 5-HT3 receptor antagonist commonly used for the prevention of postoperative nausea and vomiting, has been suggested to attenuate spinal anesthesia-induced hemodynamic instability by modulating vagal reflexes.
This prospective observational study aimed to evaluate the effects of ondansetron on hemodynamic changes following spinal anesthesia in geriatric patients undergoing urologic surgery. Hemodynamic parameters were recorded during the intraoperative period, and the incidence of hypotension, bradycardia, and vasopressor requirements were assessed.
Read the detailed description
This study was designed as a prospective observational study conducted in geriatric patients undergoing urologic surgery under spinal anesthesia. Patient enrollment and data collection were performed prospectively between December 18, 2024, and April 18, 2025. The study protocol was approved by the TABED Ethics Committee (Approval No: 1-24-840, December 18, 2024).
Ondansetron was administered according to routine clinical practice. Hemodynamic parameters, including mean arterial pressure and heart rate, were recorded at predefined time points following spinal anesthesia. The incidence of spinal anesthesia-induced hypotension, bradycardia, and the need for vasopressor support were evaluated.
Although patient enrollment and data collection were conducted prospectively, the study was registered retrospectively at ClinicalTrials.gov due to delayed trial registration.
- Conditions
- Hypotension, Bradycardia, Hypotension During Surgery, Spinal Anesthesia Induced Hemodynamic Change
- Keywords
- ondansetron, spinal anesthesia, geriatric patients, hemodynamic instability, urologic surgery
- Medical subject headings
- Hypotension, Bradycardia
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 |
|---|---|---|
| Ondansetron Group | Geriatric patients undergoing urologic surgery under spinal anesthesia who received intravenous ondansetron as part of routine clinical practice prior to spinal block. Patients were observed without investigator-directed intervention. | |
| Control Group | Geriatric patients undergoing urologic surgery under spinal anesthesia who did not receive ondansetron prior to spinal block and were managed according to routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Spinal Anesthesia-Induced Hypotension
The occurrence of spinal anesthesia-induced hypotension, defined as a decrease in mean arterial pressure of 20% or more from baseline during the intraoperative period.
Measured: rom induction of spinal anesthesia until the end of surgery
Incidence of Spinal Anesthesia-Induced Bradycardia
The occurrence of spinal anesthesia-induced bradycardia, defined as a decrease in heart rate of 20% or more from baseline during the intraoperative period.
Measured: From induction of spinal anesthesia until the end of surgery
Secondary outcomes (2)
Ephedrine Requirement
The need for intraoperative ephedrine administration to treat hypotension following spinal anesthesia.
Measured: From induction of spinal anesthesia until the end of surgery
Atropine Requirement
The need for intraoperative atropine administration to treat bradycardia following spinal anesthesia.
Measured: From induction of spinal anesthesia until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start18 Dec 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Deniz, Ankara City Hospital Bilkent
- Investigators
- Zeynep Nur Akçaboy, MD, Principal investigator, Department of Anesthesiology, Ankara City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551219
- Sponsor's protocol ID
- TABED1-24-840
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ondansetron on Hemodynamic Changes Induced by Spinal Anesthesia in Geriatric Urologic Surgery Patients
- ClinicalTrials.gov ID
- NCT07551219
- Acronym / sponsor ID
- TABED1-24-840
- Conditions
- Hypotension, Bradycardia, Hypotension During Surgery, Spinal Anesthesia Induced Hemodynamic Change
- Keywords
- ondansetron, spinal anesthesia, geriatric patients, hemodynamic instability, urologic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 24 Apr 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.
Spinal anesthesia is frequently used in urologic surgery in geriatric patients; however, it may cause significant hemodynamic changes such as hypotension and bradycardia. These changes can be more pronounced in elderly patients due to age-related physiological alterations. Ondansetron, a 5-HT3 receptor antagonist commonly used for the prevention of postoperative nausea and vomiting, has been suggested to attenuate spinal anesthesia-induced hemodynamic instability by modulating vagal reflexes.
This prospective observational study aimed to evaluate the effects of ondansetron on hemodynamic changes following spinal anesthesia in geriatric patients undergoing urologic surgery. Hemodynamic parameters were recorded during the intraoperative period, and the incidence of hypotension, bradycardia, and vasopressor requirements were assessed.
Detailed description
This study was designed as a prospective observational study conducted in geriatric patients undergoing urologic surgery under spinal anesthesia. Patient enrollment and data collection were performed prospectively between December 18, 2024, and April 18, 2025. The study protocol was approved by the TABED Ethics Committee (Approval No: 1-24-840, December 18, 2024).
Ondansetron was administered according to routine clinical practice. Hemodynamic parameters, including mean arterial pressure and heart rate, were recorded at predefined time points following spinal anesthesia. The incidence of spinal anesthesia-induced hypotension, bradycardia, and the need for vasopressor support were evaluated.
Although patient enrollment and data collection were conducted prospectively, the study was registered retrospectively at ClinicalTrials.gov due to delayed trial registration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron Group | – | –Geriatric patients undergoing urologic surgery under spinal anesthesia who received intravenous ondansetron as part of routine clinical practice prior to spinal block. Patients were observed without investigator-directed intervention. |
| Control Group | – | –Geriatric patients undergoing urologic surgery under spinal anesthesia who did not receive ondansetron prior to spinal block and were managed according to routine clinical practice. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of geriatric patients aged 65 years and older undergoing elective urologic surgery under spinal anesthesia. Patients were managed according to routine clinical practice, with or without prophylactic ondansetron administration. Perioperative hemodynamic parameters, including blood pressure and heart rate, were prospectively recorded during the intraoperative period.
Key inclusion criteria (1 listed)
- Patients aged 65 years and older Patients scheduled for elective urologic surgery under spinal anesthesia American Society of Anesthesiologists (ASA) physical status I-III Patients who received routine perioperative management, with or without ondansetron administration Patients who provided written informed consent
Key exclusion criteria (1 listed)
- Refusal or contraindication to spinal anesthesia Known hypersensitivity or contraindication to ondansetron Preexisting severe cardiac conduction abnormalities (e.g., high-grade atrioventricular block, sick sinus syndrome) Baseline bradycardia (heart rate < 50 beats per minute) Chronic use of medications significantly affecting heart rate or blood pressure (e.g., beta-blockers, calcium channel blockers, antiarrhythmic drugs) Emergency surgery Incomplete perioperative hemodynamic data
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
Incidence of Spinal Anesthesia-Induced Hypotension
Time frame: rom induction of spinal anesthesia until the end of surgery
The occurrence of spinal anesthesia-induced hypotension, defined as a decrease in mean arterial pressure of 20% or more from baseline during the intraoperative period.
Incidence of Spinal Anesthesia-Induced Bradycardia
Time frame: From induction of spinal anesthesia until the end of surgery
The occurrence of spinal anesthesia-induced bradycardia, defined as a decrease in heart rate of 20% or more from baseline during the intraoperative period.
2 secondary outcomes
Ephedrine Requirement
Time frame: From induction of spinal anesthesia until the end of surgery
Atropine Requirement
Time frame: From induction of spinal anesthesia until the end 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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Zeynep Nur Akçaboy, MD principal investigator
Department of Anesthesiology, Ankara City Hospital
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 Hypotension and Bradycardia, run by Ankara City Hospital Bilkent 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: finished, as of the sponsor's last update on 24 Apr 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?
Incidence of Spinal Anesthesia-Induced Hypotension (time frame: rom induction of spinal anesthesia until the end of surgery). The study lists 2 primary outcomes in all. 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 24 Apr 2026.