Body Mass Index and Spinal Anesthesia in Urological Surgery
16 juni 2026 uppdaterad av: Fadime Tosun, Adiyaman University
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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
120
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Adıyaman Province
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Merkez, Adıyaman Province, Turkiet (Türkiye), 02100
- Adıyaman University Faculty of Medicine Anesthesiology and Reanimation
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
- Age 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective urologic surgery under spinal anesthesia
Exclusion Criteria:
- Refusal to participate or lack of informed consent
- Contraindications to spinal anesthesia
- Height <150 cm or >190 cm
- BMI <18.5 kg/m²
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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
|
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Intraoperative ephedrine consumption (mg)
Tidsram: From spinal anesthesia induction until completion of surgery.
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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.
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From spinal anesthesia induction until completion of surgery.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Maximum sensory block level
Tidsram: During intraoperative monitoring
|
Highest thoracic dermatome level reached after intrathecal injection of 3 mL 0.5% hyperbaric bupivacaine, assessed by pinprick testing every 2 minutes.
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During intraoperative monitoring
|
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Time to reach maximum sensory block (minutes)
Tidsram: From intrathecal injection to maximum sensory level
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Time in minutes from the intrathecal injection of hyperbaric bupivacaine until the maximum sensory block level is achieved.
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From intrathecal injection to maximum sensory level
|
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Time to two-segment regression of sensory block
Tidsram: From maximum sensory block to two-dermatome regression
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Time in minutes from the maximum sensory block level until regression of sensory block by two thoracic dermatomes.
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From maximum sensory block to two-dermatome regression
|
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Time to reach Bromage score 3
Tidsram: From intrathecal injection to complete motor block
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Time in minutes from the intrathecal injection until development of complete motor block in the lower extremities (Bromage score 3)
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From intrathecal injection to complete motor block
|
|
Motor block recovery time(minutes)
Tidsram: From intrathecal injection to earliest detectable return of motor activity
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Time in minutes from the intrathecal injection until the earliest detectable return of motor function in the lower extremities.
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From intrathecal injection to earliest detectable return of motor activity
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Hemodynamic parameters
Tidsram: Baseline and every 5 minutes during surgery.,
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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.
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Baseline and every 5 minutes during surgery.,
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2022
Primärt slutförande (Faktisk)
1 december 2025
Avslutad studie (Faktisk)
1 december 2025
Studieregistreringsdatum
Först inskickad
12 juni 2026
Först inskickad som uppfyllde QC-kriterierna
16 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ADYU-AR-FT-03
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