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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03195166
Enrollment
20
Registered
2017-06-22
Start date
2017-11-03
Completion date
2020-12-31
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Keywords

elderly spinal anesthesia

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTFloTrac sensor/Vigileo

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

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

consecutive patient

Intervention model description

The aim of this study was to investigate the hemodynamic effects of continuous spinal anesthesia in elderly patients. An oral intake of 250 ml of water was taken 2 hours before surgery. Radial arterial catheter was putted under local anesthesia and connected to the FloTrac sensor/Vigileo haemodynamic monitoring system. Fluid therapy was limited to 4 ml/kg/h until tourniquet release. Subarachnoid puncture was performed at the L3-S1 interspace. An initial dose of 2,5 mg isobaric 0,5% bupivacaine was injected. 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. Investigators measured blood pressure (systolic, diastolic and mean), stroke volume and cardiac output every 5 minutes from beginning of the operation and until 2 hours after the end. Number of hypotension episodes and ephedrine consumption were noted.

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hemodynamic profile during continuous spinal anesthesia in elderlyDay 0cardiac output , L/min

Secondary

MeasureTime frameDescription
blood pressure variationDay 0systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg
ephedrine useDay 0ephedrine consumption , mg
stoke volume modificationDay 0stroke volume, L

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026