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NCT05868642 Clinical Trial

Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT

Anesthesia, Local Clinical Trial

— NINO  

Official title:
Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Nel Confronto Con la Tecnica Tradizionale Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. Trial Randomizzato Controllato

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05868642
Other study ID # 0000440
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2018
Est. completion date June 25, 2020

Study information
Verified date May 2023
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

Description:

This study aims to investigate whether a different hemodynamic effect is related to the injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional single shot injection. The data to be recorded are blood pressure and pulse rate at different timing. As secondary outcomes the investigators will record the anesthetic level achieved using the Bromage score.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date June 25, 2020
Est. primary completion date May 25, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria: - BMI 20-40 kg/m2 - ASA 1-3 - undergoing total hip arthroplasty - no controindications to subaracnhoid block - able to understand and sign a written informed consensus - METs > o = 4 Exclusion Criteria: - baseline SBP < 100 mmHg

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• subarachnoid block
subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty

Locations
Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna BO

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary SBP change SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour 60 minute
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