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NCT Number: NCT03195166

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

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.

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Key information

Conditions

Hemodynamic Instability

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kassab orthopedic Institute

Tunis, La Manouba, 2010, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FloTrac sensor/Vigileo

Diagnostic Test

blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia

Primary outcomes

  1. hemodynamic profile during continuous spinal anesthesia in elderly

    Time frame: Day 0

    cardiac output , L/min

Secondary outcomes

  1. blood pressure variation

    Time frame: Day 0

    systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg

  2. ephedrine use

    Time frame: Day 0

    ephedrine consumption , mg

  3. stoke volume modification

    Time frame: Day 0

    stroke volume, L

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2017
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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