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
About this trial
This is an interventional basic science trial for Hypotension focused on measuring hip fracture, spinal anesthesia, hypotension, injection time
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
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
NCT ID
NCT05564741
First Posted
September 29, 2022
Last Updated
October 4, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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
background
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Acute Hip Fracture and Spinal Anaesthesia Injection Time
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