Isobaric versus hyperbaric intrathecal bupivacaine: influence of specific density on blood pressure change during elective total knee arthroplasty with spinal anesthesia

Phase 1

• Conditions: Total knee arthroplasty; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2022-000857-10-BE
• Lead Sponsor: CHU de Liège

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-14
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Total knee arthroplasty with spinal anesthesia in patients >18 years old
American Society of Anesthesiologists Physical Status I or II
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

Patient refusal
Spinal anesthesia contrindications
History of lumbar arthrodesis surgery
Body Mass Index >35
Heart failure
Heart valves diseases
Uncontrolled arterial hypertension
Kidney disease (KADIGO 3 or more)
Height <160 cm or >190 cm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified