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Clinical Trials/NCT03195166
NCT03195166
Completed
Not Applicable

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

University Tunis El Manar1 site in 1 country20 target enrollmentNovember 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodynamic Instability
Sponsor
University Tunis El Manar
Enrollment
20
Locations
1
Primary Endpoint
hemodynamic profile during continuous spinal anesthesia in elderly
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 3, 2017
End Date
December 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Tunis El Manar
Responsible Party
Principal Investigator
Principal Investigator

Olfa kaabachi, MD

professor

University Tunis El Manar

Eligibility Criteria

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,
  • Cardiac ejection fraction \< 50 %,
  • valvulopathy,
  • pulmonary artery hypertension
  • and relaxation abnormality

Outcomes

Primary Outcomes

hemodynamic profile during continuous spinal anesthesia in elderly

Time Frame: Day 0

cardiac output , L/min

Secondary Outcomes

  • blood pressure variation(Day 0)
  • ephedrine use(Day 0)
  • stoke volume modification(Day 0)

Study Sites (1)

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