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Completed

NCT Number: NCT05868642

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

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

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Key information

Conditions

Anesthesia; Adverse Effect Anesthesia, Local

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subarachnoid block

Procedure

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

Primary outcomes

  1. SBP change

    Time frame: 60 minute

    SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: NINO

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 22, 2023
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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