ARTHROPLASTY, REPLACEMENT; ANESTHESIA Clinical Trial
Official title:
Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study
| NCT number | NCT02978066 |
| Other study ID # | 2010-2042-31/1 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2012 |
| Est. completion date | April 2014 |
| Verified date | September 2020 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - hip or knee arthroplasty - spinal anaesthesia - age 65 years or more Exclusion Criteria: - weight <40kg - concomitant lithium medication - written informed consent not obtained - research team unavailable |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Stroke volume in ml | the blood volume pumped by the heart at each stroke | 0-45 minutes after spinal anaesthesia | |
| Secondary | Arterial blood pressure mmHg and change from baseline | mmHg measured by arterial catheter | 0-45 minutes after spinal anaesthesia |