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

NCT05101291 | Completed

• 1 other identifier: Fractional Spinal LidCO
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Fractures; Anesthesia; Hypotension Drug-Induced; Cardiac Output, Low

Keywords

hip fracture; Spinal anaesthesia; fractional; hypotension; cardiac output; elderly patients

Outcome Measures

Primary Outcomes (4)

• Mean arterial pressure

  Mean arterial pressure change over time and in relation to intrathecal dosing

  45 minutes

• Cardiac Output

  Cardiac Output change over time and in relation to intrathecal dosing

  45 minutes

• Systemic Vascular Resistance Index

  Systemic vascular resistance indexchange over time and in relation to intrathecal dosing

  45 minutes

• Elastance

  Arterial Elastance change over time and in relation to intrathecal dosing

  45 minutes

Study Arms (1)

Fractional spinal anaesthesia

EXPERIMENTAL

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.

Drug: Bupivacain

Interventions

Bupivacain DRUG

Interventional anaesthesia provided through an indwelling spinal catheter was administered according to protocol

Also known as: Fractional spinal anaesthesia

Fractional spinal anaesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital /Mölndal

Gothenburg, Västra Götaland County, Sweden

Location

Related Publications (4)

• 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.

  PMID: 33289066 BACKGROUND

• 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.

  PMID: 22537572 BACKGROUND

• 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.

  PMID: 29040402 BACKGROUND

• 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.

  PMID: 21278153 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Hypotension; Cardiac Output, Low

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Bengt Nellgård, MD PhD

  Head of det

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Department

Model Details: Single arm, open label investigation on the hemodynamic effect of fractional spinal anaesthesia as measured by lithium dilution cardiac output monitoring

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 1, 2021
• Study Start: January 15, 2021
• Primary Completion: February 15, 2021
• Study Completion: February 16, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)