Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years

Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty

Compared to single-dose spinal anesthesia, continuous spinal anesthesia using small titrated doses of local anesthetic, was safe, efficient and provided better hemodynamic profile in elderly patients.

The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients undergoing knee arthroplasty.

Investigators use the FloTrac sensor/Vigileo haemodynamic monitoring system to assess modification blood pressure, stroke volume and cardiac output during anesthesia and specialy after every bolus of spinal anesthesia, after inflating the tourniquet and after putting it off.

they recorded number of hypotension episodes, ephedrine bolus and consumption until 2 hours after the end of surgery.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Diagnostic test: FloTrac sensor/Vigileo

Detailed Description

The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia (CSA) in elderly patients undergoing knee arthroplasty.

Inclusion criteria:

Adult patients, aged more than 65 years scheduled for elective total knee arthroplasty under regional anesthesia.

Study Design :

Patients had a transthoracic echocardiography one to three months before the surgical procedure, performed by a cardiologist.

An oral intake of 250 ml of water was taken 2 hours before surgery. In the operating room, patients received monitoring with electrocardiogram, pulse oximetry and had their blood pressure measured and recorded via an indwelling radial arterial catheter putting under local anesthesia.

This catheter was connected to the FloTrac sensor/Vigileo haemodynamic monitoring systeme to track continuously stroke volume and cardiac output.

All patients were given nasal oxygen during all the procedure to keep oxygen saturation > 95 %. Fluid therapy was limited to 4 ml/kg/h until tourniquet release.

Subarachnoid puncture was performed with a 19-Gauge Tuohy needle at the L3-S1 interspace using a midline approach. Three cm of a 22-Gauge catheter was introduced through the needle. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected through the catheter. Additional 2,5 mg isobaric 0,5% bupivacaine doses were injected every 10 minutes until sensory blockade reached T10.

Ephedrine 6 to 9 mg was given if systolic arterial pressure < 90 mmHg or < 100 mmHg with clinical signs of poor tolerance (dizziness, anxiety, dyspnea, vomiting).

Sample size We included 20 patients in this observational study.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sessi kaiser, MD; Phone Number: +21053688132; Email: kaissar_sassi@hotmail.fr
• Study Contact Backup: Name: BARGAOUI ABERAHMEN, MD; Phone Number: +21622849078; Email: bargaoui.abd@gmail.com

Study Locations

• Tunisia
  • La Manouba
    • Tunis, La Manouba, Tunisia, 2010
      • Kassab orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 83 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients, aged more than 65 years
• scheduled for elective total knee arthroplasty
• under regional anesthesia

Exclusion Criteria:

• contraindication to regional anesthesia
• or the patients who refused to give consent,
• patients with anemia (hemoglobin < 13 g/dl for male and hemoglobin < 12 g/dl for female),
• cardiac arrhythmias,
• NYHA score > 2,
• ASA > 2
• Cardiac ejection fraction < 50 %,
• valvulopathy,
• pulmonary artery hypertension
• and relaxation abnormality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hemodynamic profile; FloTrac sensor/Vigileo	Diagnostic test: FloTrac sensor/Vigileo; blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamic profile during continuous spinal anesthesia in elderly	cardiac output , L/min	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure variation	systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg	Day 0
ephedrine use	ephedrine consumption , mg	Day 0
stoke volume modification	stroke volume, L	Day 0

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Study Chair: KAABACHI OLFA, PROF, Kassab orthopedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: elderly spinal anesthesia
• Other Study ID Numbers: 101/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No