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Clinical Trials/NCT03195166
NCT03195166CompletedNot Applicable

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

University Tunis El Manar2 sites in 1 country20 target enrollmentStarted: November 3, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
hemodynamic profile during continuous spinal anesthesia in elderly

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Masking Description

consecutive patient

Eligibility Criteria

Ages
65 Years to 85 Years (Older Adult)
Sex
All
Accepts 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,
  • 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)

Investigators

Sponsor
University Tunis El Manar
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Olfa kaabachi, MD

professor

University Tunis El Manar

Study Sites (2)

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