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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05564741
Other study ID # Spinal time
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 2022
Est. completion date December 2023

Study information

Verified date October 2022
Source Sahlgrenska University Hospital, Sweden
Contact Bengt MD Nellgård, Prof
Phone +46076968680
Email bengt.nellgard@vgregion.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Norepinephrine 1 MG/ML
As proxy for hypotension we record amount of Norepinephrine given during the study time of 30 minutes

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, 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

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

Pitkänen 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. — 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 (MAP) change in MAP after spinal anesthesia 10 minutes before and 45 minutes after the intrathecal dose is given
Secondary Cardiac Output (CO) CO change over time and relation to the speed of injection of the spinal anesthesia 10 minutes before and 45 minutes after the intrathecal dose is given
Secondary Systemic vascular resistance over time and relation to the speed of injection of the spinal anesthesia 10 minutes before and 45 minutes after the intrathecal dose is given
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