Clinical trial NCT03195166: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Keywords: elderly spinal anesthesia
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: hemodynamic profile during continuous spinal anesthesia in elderly
timeFrame: Day 0
Secondary outcomes:
measure: blood pressure variation
timeFrame: Day 0
measure: ephedrine use
timeFrame: Day 0
measure: stoke volume modification
timeFrame: Day 0
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Kassab orthopedic Institute
state: La Manouba
Study officials:
affiliation: KASSAB ORTHOPEDIC INSTITUTE
name: KAABACHI OLFA, PROF
role: STUDY_CHAIR
References: