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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

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.


Condition or disease Intervention/treatment Phase
Hemodynamic Instability Diagnostic Test: FloTrac sensor/Vigileo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years Undergoing Total Knee Arthroplasty
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Arm Intervention/treatment
Experimental: hemodynamic profile
FloTrac sensor/Vigileo
Diagnostic Test: FloTrac sensor/Vigileo
blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia




Primary Outcome Measures :
  1. hemodynamic profile during continuous spinal anesthesia in elderly [ Time Frame: Day 0 ]
    cardiac output , L/min


Secondary Outcome Measures :
  1. blood pressure variation [ Time Frame: Day 0 ]
    systolic blood pressure, diastolic blood pressure, mean blood pressure, mmHg

  2. ephedrine use [ Time Frame: Day 0 ]
    ephedrine consumption , mg

  3. stoke volume modification [ Time Frame: Day 0 ]
    stroke volume, L



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
  • ASA > 2
  • Cardiac ejection fraction < 50 %,
  • valvulopathy,
  • pulmonary artery hypertension
  • and relaxation abnormality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195166


Contacts
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Contact: SESSI KAISER, MD +21053688132 kaissar_sassi@hotmail.fr
Contact: BARGAOUI ABERAHMEN, MD +21622849078 bargaoui.abd@gmail.com

Locations
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Tunisia
Kassab orthopedic Institute Recruiting
Tunis, La Manouba, Tunisia, 2010
Contact: Sessi kaiser, MD    +21053688132    kaissar_sassi@hotmail.fr   
Contact: BARGAOUI ABERAHMEN, MD    +21622849078    bargaoui.abd@gmail.com   
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Chair: KAABACHI OLFA, PROF KASSAB ORTHOPEDIC INSTITUTE

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Responsible Party: Kaabachi olfa, professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03195166     History of Changes
Other Study ID Numbers: 101/2017
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaabachi olfa, University Tunis El Manar:
elderly spinal anesthesia
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs