Urologic Surgical ProceduresNCT07653217
Body Mass Index and Spinal Anesthesia in Urological Surgery
An observational study of Urologic Surgical Procedures and Body Mass Index, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
This single-center prospective observational study investigates the effect of body mass index (BMI) on intraoperative vasopressor requirements and spinal block characteristics in adult patients undergoing urological surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Surgical Procedures, Body Mass Index, Vasopressor Therapy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with ASA physical status I-II scheduled for elective urological surgery in the lithotomy position under spinal anesthesia at a tertiary care hospital. All participants had a BMI ≥18.5 kg/m² and were classified into two groups according to BMI (Group L: BMI <27.5 kg/m², Group H: BMI ≥27.5 kg/m²). Patients with contraindications to spinal anesthesia, extreme height (<150 cm or >190 cm), or who declined participation were excluded.
Who may be able to join
- Age 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective urologic surgery under spinal anesthesia
Who cannot join
- Refusal to participate or lack of informed consent
- Contraindications to spinal anesthesia
- Height <150 cm or >190 cm
- BMI <18.5 kg/m²
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adıyaman University Faculty of Medicine Anesthesiology and Reanimation
Merkez, Adıyaman Province, 02100
About this study
Official title: The Effect of Body Mass Index on Vasopressor Use, Block Dynamics, and Hemodynamic Responses in Urological Surgery Cases Undergoing Spinal Anesthesia: Prospective Observational Study
This single-center prospective observational study investigates the effect of body mass index (BMI) on intraoperative vasopressor requirements and spinal block characteristics in adult patients undergoing urological surgery under spinal anesthesia. Participants are classified into two cohorts according to BMI (<27.5 kg/m² and ≥27.5 kg/m²).Patient enrollment for this prospective observational study started before trial registration; therefore, this record represents a retrospective registration.
Read the detailed description
This is a single-center prospective observational study conducted at a tertiary care hospital between May 2022 and December 2025. The study aims to evaluate the relationship between body mass index (BMI) and intraoperative ephedrine requirements, sensory and motor block characteristics, and hemodynamic responses in adult patients undergoing elective urologic surgery in the lithotomy position under spinal anesthesia. All patients received a standardized intrathecal dose of 3 mL 0.5% hyperbaric bupivacaine, and intraoperative hypotension was treated with intravenous ephedrine according to a predefined protocol. Patient enrollment for this prospective observational study began before registration of the study; therefore, this record represents a retrospective registration. Ethics approval was obtained from the institutional ethics committee prior to patient recruitment, and written informed consent was obtained from all participants.
- Keywords
- Body Mass Index, Ephedrine, Hemodynamic Response, Sensory Block
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 |
|---|---|---|
| BMI <27.5 kg/m² (Group L) | Adult patients undergoing elective urologic surgery under spinal anesthesia with a body mass index (BMI) <27.5 kg/m² | |
| BMI ≥27.5 kg/m² (Group H) | Adult patients undergoing elective urologic surgery under spinal anesthesia with a body mass index (BMI) ≥27.5 kg/m². |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative ephedrine consumption (mg)
Cumulative intravenous ephedrine dose administered to treat hypotension (systolic arterial pressure <90 mmHg or >30% decrease from baseline) from the time of spinal anesthesia induction until the end of the surgical procedure.
Measured: From spinal anesthesia induction until completion of surgery.
Secondary outcomes (6)
Maximum sensory block level
Highest thoracic dermatome level reached after intrathecal injection of 3 mL 0.5% hyperbaric bupivacaine, assessed by pinprick testing every 2 minutes.
Measured: During intraoperative monitoring
Time to reach maximum sensory block (minutes)
Time in minutes from the intrathecal injection of hyperbaric bupivacaine until the maximum sensory block level is achieved.
Measured: From intrathecal injection to maximum sensory level
Time to two-segment regression of sensory block
Time in minutes from the maximum sensory block level until regression of sensory block by two thoracic dermatomes.
Measured: From maximum sensory block to two-dermatome regression
Time to reach Bromage score 3
Time in minutes from the intrathecal injection until development of complete motor block in the lower extremities (Bromage score 3)
Measured: From intrathecal injection to complete motor block
Motor block recovery time(minutes)
Time in minutes from the intrathecal injection until the earliest detectable return of motor function in the lower extremities.
Measured: From intrathecal injection to earliest detectable return of motor activity
Hemodynamic parameters
Noninvasive systolic and diastolic arterial pressure and heart rate measured at baseline (before spinal anesthesia) and then at 5-minute intervals throughout the surgical procedure.
Measured: Baseline and every 5 minutes during surgery.,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 May 2022
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic Surgical ProceduresStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Tosun, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653217
- Sponsor's protocol ID
- ADYU-AR-FT-03
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Mass Index on Vasopressor Use, Block Dynamics, and Hemodynamic Responses in Urological Surgery Cases Undergoing Spinal Anesthesia: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07653217
- Acronym / sponsor ID
- ADYU-AR-FT-03
- Keywords
- Body Mass Index, Ephedrine, Hemodynamic Response, Sensory Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Jun 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 single-center prospective observational study investigates the effect of body mass index (BMI) on intraoperative vasopressor requirements and spinal block characteristics in adult patients undergoing urological surgery under spinal anesthesia. Participants are classified into two cohorts according to BMI (<27.5 kg/m² and ≥27.5 kg/m²).Patient enrollment for this prospective observational study started before trial registration; therefore, this record represents a retrospective registration.
Detailed description
This is a single-center prospective observational study conducted at a tertiary care hospital between May 2022 and December 2025. The study aims to evaluate the relationship between body mass index (BMI) and intraoperative ephedrine requirements, sensory and motor block characteristics, and hemodynamic responses in adult patients undergoing elective urologic surgery in the lithotomy position under spinal anesthesia. All patients received a standardized intrathecal dose of 3 mL 0.5% hyperbaric bupivacaine, and intraoperative hypotension was treated with intravenous ephedrine according to a predefined protocol. Patient enrollment for this prospective observational study began before registration of the study; therefore, this record represents a retrospective registration. Ethics approval was obtained from the institutional ethics committee prior to patient recruitment, and written informed consent was obtained from all participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI <27.5 kg/m² (Group L) | – | –Adult patients undergoing elective urologic surgery under spinal anesthesia with a body mass index (BMI) <27.5 kg/m² |
| BMI ≥27.5 kg/m² (Group H) | – | –Adult patients undergoing elective urologic surgery under spinal anesthesia with a body mass index (BMI) ≥27.5 kg/m². |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with ASA physical status I-II scheduled for elective urological surgery in the lithotomy position under spinal anesthesia at a tertiary care hospital. All participants had a BMI ≥18.5 kg/m² and were classified into two groups according to BMI (Group L: BMI <27.5 kg/m², Group H: BMI ≥27.5 kg/m²). Patients with contraindications to spinal anesthesia, extreme height (<150 cm or >190 cm), or who declined participation were excluded.
Key inclusion criteria (3 listed)
- Age 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective urologic surgery under spinal anesthesia
Key exclusion criteria (4 listed)
- Refusal to participate or lack of informed consent
- Contraindications to spinal anesthesia
- Height <150 cm or >190 cm
- BMI <18.5 kg/m²
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
Intraoperative ephedrine consumption (mg)
Time frame: From spinal anesthesia induction until completion of surgery.
Cumulative intravenous ephedrine dose administered to treat hypotension (systolic arterial pressure <90 mmHg or >30% decrease from baseline) from the time of spinal anesthesia induction until the end of the surgical procedure.
6 secondary outcomes
Maximum sensory block level
Time frame: During intraoperative monitoring
Time to reach maximum sensory block (minutes)
Time frame: From intrathecal injection to maximum sensory level
Time to two-segment regression of sensory block
Time frame: From maximum sensory block to two-dermatome regression
Time to reach Bromage score 3
Time frame: From intrathecal injection to complete motor block
Motor block recovery time(minutes)
Time frame: From intrathecal injection to earliest detectable return of motor activity
Hemodynamic parameters
Time frame: Baseline and every 5 minutes during 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 17 Jun 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.
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?
An observational study of Urologic Surgical Procedures and Body Mass Index, run by Adiyaman University 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 3 inclusion and 4 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 17 Jun 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?
Intraoperative ephedrine consumption (mg) (time frame: From spinal anesthesia induction until completion of surgery.). 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 17 Jun 2026.