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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195166
• Other study ID #: 101/2017
• Status: Completed
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2024
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Diagnostic Test:
• FloTrac sensor/Vigileo
blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia

Locations

Country	Name	City	State
Tunisia	Kassab orthopedic Institute	Tunis	La Manouba

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic profile during continuous spinal anesthesia in elderly	cardiac output , L/min	Day 0
Secondary	blood pressure variation	systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg	Day 0
Secondary	ephedrine use	ephedrine consumption , mg	Day 0
Secondary	stoke volume modification	stroke volume, L	Day 0