Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years
- Conditions
- Hemodynamic Instability
- Interventions
- Diagnostic Test: FloTrac sensor/Vigileo
- Registration Number
- NCT03195166
- Lead Sponsor
- University Tunis El Manar
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Adult patients, aged more than 65 years
- scheduled for elective total knee arthroplasty
- under regional anesthesia
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description hemodynamic profile FloTrac sensor/Vigileo FloTrac sensor/Vigileo
- Primary Outcome Measures
Name Time Method hemodynamic profile during continuous spinal anesthesia in elderly Day 0 cardiac output , L/min
- Secondary Outcome Measures
Name Time Method blood pressure variation Day 0 systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg
ephedrine use Day 0 ephedrine consumption , mg
stoke volume modification Day 0 stroke volume, L
Trial Locations
- Locations (1)
Kassab orthopedic Institute
🇹🇳Tunis, La Manouba, Tunisia
Kassab orthopedic Institute🇹🇳Tunis, La Manouba, Tunisia