Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

NCT ID: NCT03743116

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-13

Study Completion Date

2020-03-01

Brief Summary

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Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

Detailed Description

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Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization.

Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.

The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.

Conditions

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Orthostatic Intolerance Orthostatic Hypotension Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthostatic intolerant (OI)

Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilisation

No interventions assigned to this group

Orthostatic tolerant (OT)

Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg) during mobilisation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Written informed consent
* Patients that speak and understand Danish
* Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting

Exclusion Criteria

* Alcohol or drug abuse
* Cognitive dysfunction
* Known orthostatic hypotension
* Use of anxiolytic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kehlet, Henrik, M.D., Ph.D.

INDIV

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Marija Hristovska

Principal Investigator, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana-Marija Hristovska, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Hvidovre Hospital, Copenhagen

Locations

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Hvidovre University Hosptial

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18049929

Identifier Type: -

Identifier Source: org_study_id

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