Postspinal Hypotension and Cardiac Performance in the Elderly

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT02978066
• Collaborator: (none)
• Enrollment: 20
• Duration (Months): 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARTHROPLASTY, REPLACEMENT; ANESTHESIA	Other: Spinal anaesthesia

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Outcome Measures

Primary Outcome Measures

1. Stroke volume in ml [0-45 minutes after spinal anaesthesia]

   the blood volume pumped by the heart at each stroke

Secondary Outcome Measures

1. Arterial blood pressure mmHg and change from baseline [0-45 minutes after spinal anaesthesia]

   mmHg measured by arterial catheter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sigridur Kalman, MD Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02978066
• Other Study ID Numbers: 2010-2042-31/1
• First Posted: Nov 30, 2016
• Last Update Posted: Sep 18, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hypotension; Anesthetics

Study Results

No Results Posted as of Sep 18, 2020