Body Mass Index and Spinal Anesthesia in Urological Surgery
16. juni 2026 oppdatert 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
120
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Adıyaman Province
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Merkez, Adıyaman Province, Tyrkia (Türkiye), 02100
- Adıyaman University Faculty of Medicine Anesthesiology and Reanimation
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Intraoperative ephedrine consumption (mg)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum sensory block level
Tidsramme: During intraoperative monitoring
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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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Motor block recovery time(minutes)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2022
Primær fullføring (Faktiske)
1. desember 2025
Studiet fullført (Faktiske)
1. desember 2025
Datoer for studieregistrering
Først innsendt
12. juni 2026
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ADYU-AR-FT-03
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