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Acute Hip Fracture and Spinal Anaesthesia Injection Time

Primary Purpose

Hypotension, Hip Fractures, Anesthesia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Norepinephrine 1 MG/ML
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypotension focused on measuring hip fracture, spinal anesthesia, hypotension, injection time

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. >65 years of age
  2. patient with hip fracture
  3. ASA >/=2
  4. scheduled for acute surgery in spinal anesthesia, 5. mentally intact to give informed consent

Exclusion Criteria:

  1. anticoagulantion medication
  2. planned for general anesthesia
  3. surgery delayed > 72h
  4. lack of informed consent.
  5. severe aortic stenosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    15 s injection time

    90 s injection time

    Arm Description

    Patients in group A will be given the spinal anesthesia with an injection time of 15 s

    Patients in group B will be given the spinal anesthesia with an injection time of 90 s

    Outcomes

    Primary Outcome Measures

    Mean arterial pressure (MAP)
    change in MAP after spinal anesthesia

    Secondary Outcome Measures

    Cardiac Output (CO)
    CO change over time and relation to the speed of injection of the spinal anesthesia
    Systemic vascular resistance over time and relation to the speed of injection of the spinal anesthesia

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    October 4, 2022
    Sponsor
    Sahlgrenska University Hospital, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05564741
    Brief Title
    Acute Hip Fracture and Spinal Anaesthesia Injection Time
    Official Title
    Hemodynamic Effects During Fast vs Slow Injection Time of Spinal Anaesthesia in Elderly Patients With Acute Hip Fracture .
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sahlgrenska University Hospital, Sweden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The systemic effects of spinal anesthesia is not fully known. Our aim of this study is to assess whether there is a difference in hemodynamic effects if the spinal dose is given fast (15s) or slow (90s) in elderly patients with acute hip fracture (AHF). Ninety (n=90) patients with AHF planned for surgery within 72h at our hospital will be enrolled in the study and randomly devided into two groups. The patients will receive one predetermined dose of spinal anesthesia followed by an advanced minimally-invasive hemodynamic monitoring through an arterial line using FloTrac-system. The hemodynamic parameters will be conducted 10 minutes prior to the spinal anaesthesia and 30 minutes after the spinal block is given. Hypotension was defined as a fall in MAP > 30 % or a MAP <65mmHg.
    Detailed Description
    Both general and spinal anesthesia is known for inducing hypotension, which may be a problem for the elderly patients, often with many co-morbidities, causing a risk of organ hypoperfusion. At our clinic the investigators have a great experience with the neuraxial technique when operating these patients. Based on clinical experience the investigators hypothesise that a slow injection rate of the spinal dos would reduce the incidence and degree of hypotension. The investigators also aim to study the changes in the hemodynamic response between the groups in more detail as mentioned below. Patients planned for acute hip fracture surgery in spinal anaesthesia at our hospital and fulfills the inclusion criteria will be included in our study. The investigators plan to include 90 patients, randomized in two groups where Group A will be given a spinal anaesthesia in 15s and Group B in 90s. After arriving to the preoperative area, the patients will be given 5 L oxygen on a face mask and a standard monitoring with ECG, pulse- oximetry will be started, followed by the placement of a venous cannula and a radial arterial line. The patients will also be given a fascia iliaca compartment block (FIC) with ropivacaine 3,75 mg/ml 35-40 ml for comfort. In addition, the FloTrac system will be set up, using the existing arterial line, for advanced hemodynamic monitoring including invasive mean arterial pressure (MAP), Cardiac Index (CI), Heart Rate (HR), Stroke Volume (SV) and System Vascular Resistance (SVR)/ (SVRI). A lumbal spinal anesthesia will be performed using a 25G pencil point needle. The intrathecal dose of anesthesia consists of isobar bupivacaine 5mg/ml 2,4 ml and fentanyl 50ug/ml 0,4ml. Sensory level will be monitored by "cold spray" Hypotension will be defined as a fall in MAP by >30% or MAP < 65 mmHg. As an surrogate factor for the aggregated time of hypotension the total amount of given vasopressor will be calculated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension, Hip Fractures, Anesthesia
    Keywords
    hip fracture, spinal anesthesia, hypotension, injection time

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    15 s injection time
    Arm Type
    Active Comparator
    Arm Description
    Patients in group A will be given the spinal anesthesia with an injection time of 15 s
    Arm Title
    90 s injection time
    Arm Type
    Active Comparator
    Arm Description
    Patients in group B will be given the spinal anesthesia with an injection time of 90 s
    Intervention Type
    Drug
    Intervention Name(s)
    Norepinephrine 1 MG/ML
    Intervention Description
    As proxy for hypotension we record amount of Norepinephrine given during the study time of 30 minutes
    Primary Outcome Measure Information:
    Title
    Mean arterial pressure (MAP)
    Description
    change in MAP after spinal anesthesia
    Time Frame
    10 minutes before and 45 minutes after the intrathecal dose is given
    Secondary Outcome Measure Information:
    Title
    Cardiac Output (CO)
    Description
    CO change over time and relation to the speed of injection of the spinal anesthesia
    Time Frame
    10 minutes before and 45 minutes after the intrathecal dose is given
    Title
    Systemic vascular resistance over time and relation to the speed of injection of the spinal anesthesia
    Time Frame
    10 minutes before and 45 minutes after the intrathecal dose is given

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >65 years of age patient with hip fracture ASA >/=2 scheduled for acute surgery in spinal anesthesia, 5. mentally intact to give informed consent Exclusion Criteria: anticoagulantion medication planned for general anesthesia surgery delayed > 72h lack of informed consent. severe aortic stenosis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bengt MD Nellgård, Prof
    Phone
    +46076968680
    Email
    bengt.nellgard@vgregion.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pernilla MD Eklöf
    Phone
    +46737268148
    Email
    pernilla.eklof@vgregion.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bengt MD Nellgård, Prof
    Organizational Affiliation
    Sahlgrenska University Hospital /Mölndal, Sweden
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33289066
    Citation
    Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.
    Results Reference
    background
    PubMed Identifier
    22537572
    Citation
    Nakasuji M, Suh SH, Nomura M, Nakamura M, Imanaka N, Tanaka M, Nakasuji K. Hypotension from spinal anesthesia in patients aged greater than 80 years is due to a decrease in systemic vascular resistance. J Clin Anesth. 2012 May;24(3):201-6. doi: 10.1016/j.jclinane.2011.07.014.
    Results Reference
    background
    PubMed Identifier
    21278153
    Citation
    Wiles MD, Moran CG, Sahota O, Moppett IK. Nottingham Hip Fracture Score as a predictor of one year mortality in patients undergoing surgical repair of fractured neck of femur. Br J Anaesth. 2011 Apr;106(4):501-4. doi: 10.1093/bja/aeq405. Epub 2011 Jan 28.
    Results Reference
    background
    PubMed Identifier
    1514336
    Citation
    Pitkanen M, Rosenberg P, Silvanto M, Tuominen M. Haemodynamic changes during spinal anaesthesia with slow continuous infusion or single dose of plain bupivacaine. Acta Anaesthesiol Scand. 1992 Aug;36(6):526-9. doi: 10.1111/j.1399-6576.1992.tb03512.x.
    Results Reference
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    Acute Hip Fracture and Spinal Anaesthesia Injection Time

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