NCT02978066

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

November 28, 2016

Last Update Submit

September 16, 2020

Conditions

ARTHROPLASTY, REPLACEMENT; ANESTHESIA

Outcome Measures

Primary Outcomes (1)

  • Stroke volume in ml

    the blood volume pumped by the heart at each stroke

    0-45 minutes after spinal anaesthesia

Secondary Outcomes (1)

  • Arterial blood pressure mmHg and change from baseline

    0-45 minutes after spinal anaesthesia

Interventions

Spinal anaesthesiaOTHER

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 years or older scheduled for hip or knee arthroplasty in spinal anaesthesia. Exclusion criteria were: (i) weight \<40kg; (ii) concomitant lithium medication; (iv) informed consent not obtained; (v) research team unavailable

You may qualify if:

  • hip or knee arthroplasty
  • spinal anaesthesia
  • age 65 years or more

You may not qualify if:

  • weight \<40kg
  • concomitant lithium medication
  • written informed consent not obtained
  • research team unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Professor

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share