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

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ClinicalTrials.gov Identifier: NCT03195166
Recruitment Status : Unknown
Verified October 2017 by Kaabachi olfa, University Tunis El Manar.
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Kaabachi olfa, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE June 4, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE October 3, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
hemodynamic profile during continuous spinal anesthesia in elderly [ Time Frame: Day 0 ]
cardiac output , L/min
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
hemodynamic profile during continuous spinal anesthesia in elderly [ Time Frame: Day 0 ]
cardiac output
Change History Complete list of historical versions of study NCT03195166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
  • blood pressure variation [ Time Frame: Day 0 ]
    systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg
  • ephedrine use [ Time Frame: Day 0 ]
    ephedrine consumption , mg
  • stoke volume modification [ Time Frame: Day 0 ]
    stroke volume, L
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • blood pressure [ Time Frame: Day 0 ]
    blood pressure
  • ephedrine [ Time Frame: Day 0 ]
    ephedrine consumption
  • stoke volume [ Time Frame: Day 0 ]
    stroke volume
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years
Official Title  ICMJE Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Masking Description:
consecutive patient
Primary Purpose: Diagnostic
Condition  ICMJE Hemodynamic Instability
Intervention  ICMJE Diagnostic Test: FloTrac sensor/Vigileo
blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia
Study Arms  ICMJE Experimental: hemodynamic profile
FloTrac sensor/Vigileo
Intervention: Diagnostic Test: FloTrac sensor/Vigileo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195166
Other Study ID Numbers  ICMJE 101/2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaabachi olfa, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: KAABACHI OLFA, PROF KASSAB ORTHOPEDIC INSTITUTE
PRS Account University Tunis El Manar
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP