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

NCT03195166 | Completed

• 1 other identifier: 101/2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Keywords

elderly spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• hemodynamic profile during continuous spinal anesthesia in elderly

  cardiac output , L/min

  Day 0

Secondary Outcomes (3)

• blood pressure variation

  Day 0

• ephedrine use

  Day 0

• stoke volume modification

  Day 0

Study Arms (1)

hemodynamic profile

EXPERIMENTAL

FloTrac sensor/Vigileo

Diagnostic Test: FloTrac sensor/Vigileo

Interventions

FloTrac sensor/Vigileo DIAGNOSTIC_TEST

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

hemodynamic profile

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Adult patients, aged more than 65 years
• scheduled for elective total knee arthroplasty
• under regional anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Kassab orthopedic Institute

Tunis, La Manouba, 2010, Tunisia

Location

Study Officials

• KAABACHI OLFA, PROF

  KASSAB ORTHOPEDIC INSTITUTE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: consecutive patient
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 22, 2017
• Study Start: November 3, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)