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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101291
• Other study ID #: Fractional Spinal LidCO
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: February 16, 2021

Study information

• Verified date: October 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 16, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Cardiac Output, Low
• Fractures, Bone
• Hip Fractures
• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Bupivacain
Interventional anaesthesia provided through an indwelling spinal catheter was administered according to protocol

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital /Mölndal	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	Mean arterial pressure change over time and in relation to intrathecal dosing	45 minutes
Primary	Cardiac Output	Cardiac Output change over time and in relation to intrathecal dosing	45 minutes
Primary	Systemic Vascular Resistance Index	Systemic vascular resistance indexchange over time and in relation to intrathecal dosing	45 minutes
Primary	Elastance	Arterial Elastance change over time and in relation to intrathecal dosing	45 minutes