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Fractional Spinal Anesthesia and Systemic Hemodynamics in Frail Elderly Hip Fracture Patients.

Primary Purpose

Hip Fractures, Anesthesia, Hypotension Drug-Induced

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bupivacain
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hip Fractures focused on measuring hip fracture, Spinal anaesthesia; fractional, hypotension, cardiac output, elderly patients

Eligibility Criteria

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

Inclusion Criteria:

  1. patient with hip fracture,
  2. >65 years of age,
  3. ASA ≥2, 4) scheduled for neuraxial anaesthesia and 5) mentally intact to give informed consent. This could also be given by next-of-kin, if the patient was cognitively impaired.

Exclusion Criteria:

  1. lithium or anticoagulation medication,
  2. planned for general anaesthesia,
  3. ongoing atrial fibrillation,
  4. if surgery was delayed >72 hours,
  5. lack of informed consent and
  6. patient agitation requiring intermittent sedation.

Sites / Locations

  • Sahlgrenska University Hospital /Mölndal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fractional spinal anaesthesia

Arm Description

After FIC block or femoral nerve block with ropivacaine 3.5mg/ml 20-40ml. The LiDCOplus was calibrated with 0.3-0.45 mmol lithium based on body weight. After calibration and baseline parameter registration, the LiDCOplus system provided cardiac output variables A dural puncture by a 18G Tuohy needle was performed either between the L2 - L3 or the L3 - L4 interspaces, preferably using a mid-line approach. A catheter 20G was then inserted 4-5 cm into the intrathecal space. A solution (10 ml) of 1.5 mg/ml bupivacaine and 10 µg/ml fentanyl was prepared. Intrathecal anaesthesia was induced by giving 1,5 ml (2.25 mg of bupivacaine and 15 µg of fentanyl) of the solution, followed by a second 1.5 ml injection after 25 min. MAP was maintained with a norepinephrine to target a MAP >65mmHg or to avoid a > 30% decline in MAP from baseline. Invasive haemodynamic parameters were recorded every 5 min for 45 min after initial intrathecal dose was given.

Outcomes

Primary Outcome Measures

Mean arterial pressure
Mean arterial pressure change over time and in relation to intrathecal dosing
Cardiac Output
Cardiac Output change over time and in relation to intrathecal dosing
Systemic Vascular Resistance Index
Systemic vascular resistance indexchange over time and in relation to intrathecal dosing
Elastance
Arterial Elastance change over time and in relation to intrathecal dosing

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
October 19, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05101291
Brief Title
Fractional Spinal Anesthesia and Systemic Hemodynamics in Frail Elderly Hip Fracture Patients.
Official Title
Fractional Spinal Anesthesia and Systemic Hemodynamics in Frail Elderly Hip Fracture Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
February 15, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aging and frailty make the elderly patients susceptible to hypotension following spinal anaesthesia. The systemic haemodynamic effects of spinal anaesthesia are not well known. In this study, we examine the systemic haemodynamic effects of fractional spinal anaesthesia following intermittent microdosing of a local anesthetic and an opioid. We included 15 patients aged over 65 with considerable comorbidities, planned for emergency hip fracture repair. Patients received a spinal catheter and cardiac output monitoring using the LiDCOplus system. Invasive mean arterial pressure (MAP), cardiac index, systemic vascular resistance index, heart rate and stroke volume index were registered. Two doses of bupivacaine 2,25 mg and fentanyl 15µg were administered with 25 minutes in between. Hypotension was defined as a fall in MAP by >30% or a MAP <65 mmHg
Detailed Description
We daily screened patients planned for hip fracture surgery and these were identified through the theatre planning software (Orbit, TietoEVRY, Espoo, Finland). Nottingham Hip Fracture Score was calculated. This scoring system includes objective factors like age, sex, dementia, previous cancer, living facility and comorbidity. NHFS varies from 1-10 with higher numbers correlated to higher 30-day mortality. ASA grade was also recorded after study inclusion. After arriving to the preoperative area, patients were given 5 liters of oxygen on a face mask and ECG and pulse-oximetry monitoring were started. Oral premedication with standardized doses of paracetamol and oxycodone was given orally, followed by the placement of a venous 18G cannula in an antecubital vein and a radial arterial catheter (20G). The patient was also given a fascia iliaca compartment (FIC) block, or an ultrasound guided femoral nerve block with ropivacaine 3.5mg/ml 20-40ml, to decrease discomfort when given the neuraxial block. In addition, the LiDCOplus (LiDCO Group Plc, London, England) system was set up according to manufacturer's instructions. The system was calibrated with 0.3-0.45 mmol lithium chloride depending on body weight. After calibration and baseline parameter registration, the LiDCOplus system provided cardiac output variables and based on these and the invasive blood pressure, haemodynamic variables could be derived. Following aseptic skin preparation of the lumbar area, a subarachnoid puncture by a 18G Tuohy needle was performed either between the L2 - L3 or the L3 - L4 interspaces, preferably using a mid-line approach. An intrathecal catheter 20G was then inserted 4-5 cm into the intrathecal space. This technique of a continues spinal anaesthesia (CSA) was performed on all patients by one physician (FO). A solution (10 ml) containing 1.5 mg/ml bupivacaine and 10 µg/ml fentanyl was prepared. Intrathecal anaesthesia was induced by giving 1,5 ml (2.25 mg of bupivacaine and 15 µg of fentanyl) of the solution, followed by a second 1.5 ml injection after 25 min (i.e., a total intrathecal dos of 4.5 mg of bupivacaine and 30 µg of fentanyl). Sensory level was monitored by "cold spray". Hemodynamic recordings were performed every 5 minutes up until 45 minutes after initial intrathecal dose when research monitoring was terminated. The patient was then operated in the pre-planned time slot and was further managed at the discretion of the attending anesthetist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Anesthesia, Hypotension Drug-Induced, Cardiac Output, Low
Keywords
hip fracture, Spinal anaesthesia; fractional, hypotension, cardiac output, elderly patients

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm, open label investigation on the hemodynamic effect of fractional spinal anaesthesia as measured by lithium dilution cardiac output monitoring
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional spinal anaesthesia
Arm Type
Experimental
Arm Description
After FIC block or femoral nerve block with ropivacaine 3.5mg/ml 20-40ml. The LiDCOplus was calibrated with 0.3-0.45 mmol lithium based on body weight. After calibration and baseline parameter registration, the LiDCOplus system provided cardiac output variables A dural puncture by a 18G Tuohy needle was performed either between the L2 - L3 or the L3 - L4 interspaces, preferably using a mid-line approach. A catheter 20G was then inserted 4-5 cm into the intrathecal space. A solution (10 ml) of 1.5 mg/ml bupivacaine and 10 µg/ml fentanyl was prepared. Intrathecal anaesthesia was induced by giving 1,5 ml (2.25 mg of bupivacaine and 15 µg of fentanyl) of the solution, followed by a second 1.5 ml injection after 25 min. MAP was maintained with a norepinephrine to target a MAP >65mmHg or to avoid a > 30% decline in MAP from baseline. Invasive haemodynamic parameters were recorded every 5 min for 45 min after initial intrathecal dose was given.
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
Fractional spinal anaesthesia
Intervention Description
Interventional anaesthesia provided through an indwelling spinal catheter was administered according to protocol
Primary Outcome Measure Information:
Title
Mean arterial pressure
Description
Mean arterial pressure change over time and in relation to intrathecal dosing
Time Frame
45 minutes
Title
Cardiac Output
Description
Cardiac Output change over time and in relation to intrathecal dosing
Time Frame
45 minutes
Title
Systemic Vascular Resistance Index
Description
Systemic vascular resistance indexchange over time and in relation to intrathecal dosing
Time Frame
45 minutes
Title
Elastance
Description
Arterial Elastance change over time and in relation to intrathecal dosing
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with hip fracture, >65 years of age, ASA ≥2, 4) scheduled for neuraxial anaesthesia and 5) mentally intact to give informed consent. This could also be given by next-of-kin, if the patient was cognitively impaired. Exclusion Criteria: lithium or anticoagulation medication, planned for general anaesthesia, ongoing atrial fibrillation, if surgery was delayed >72 hours, lack of informed consent and patient agitation requiring intermittent sedation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Nellgård, MD PhD
Organizational Affiliation
Head of det
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital /Mölndal
City
Gothenburg
State/Province
Västra Götaland
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The number of participants is low and anonymity would be difficult to guarantee.
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
29040402
Citation
Jakobsson J, Kalman SH, Lindeberg-Lindvet M, Bartha E. Is postspinal hypotension a sign of impaired cardiac performance in the elderly? An observational mechanistic study. Br J Anaesth. 2017 Dec 1;119(6):1178-1185. doi: 10.1093/bja/aex274.
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
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Fractional Spinal Anesthesia and Systemic Hemodynamics in Frail Elderly Hip Fracture Patients.

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