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

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

Tracking Information

• First Submitted Date: June 4, 2017
• First Posted Date: June 22, 2017
• Last Update Posted Date: October 16, 2018
• Actual Study Start Date: October 3, 2017
• Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2017)

hemodynamic profile during continuous spinal anesthesia in elderly [ Time Frame: Day 0 ]

cardiac output , L/min

Original Primary Outcome Measures (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 (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 (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: Hemodynamic Effects of Continuous Spinal Anesthesia in Patient Aged Over 65 Years
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Hemodynamic Instability

Intervention

Diagnostic Test: FloTrac sensor/Vigileo

blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia

Study Arms

Experimental: hemodynamic profile

FloTrac sensor/Vigileo

Intervention: Diagnostic Test: FloTrac sensor/Vigileo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 19, 2017): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2019
• Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

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,
• ASA > 2
• Cardiac ejection fraction < 50 %,
• valvulopathy,
• pulmonary artery hypertension
• and relaxation abnormality

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years to 85 Years (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tunisia

Administrative Information

• NCT Number: NCT03195166
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Kaabachi olfa, University Tunis El Manar
• Study Sponsor: University Tunis El Manar
• Collaborators: Not Provided

Investigators

• Study Chair: KAABACHI OLFA, PROF; KASSAB ORTHOPEDIC INSTITUTE

• PRS Account: University Tunis El Manar
• Verification Date: October 2017