The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty

An observational study of Anesthesia, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily… Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Anesthesia
What is being tested?: Blood drawn
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2014to 1 Sep 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients scheduled for primary total knee arthroplasty who meet the qualifications will be consented prior to the surgery.

Who may be able to join

Non- inflammatory degenerative joint disease of the knee
Patients scheduled for unilateral primary total Knee arthroplasty
Age between 40 and 80 years
Hypotensive spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.

Who cannot join

Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
Congestive Heart Failure (at least one medication to treat congestive heart failure)
Coronary artery disease (s/p bypass, stent or AMI)
Kidney insufficiency (creatinine > 1.5)

Show all 10Show fewer

Aortic or mitral valve disease
Pulmonary hypertension
Revision Knee Surgery
Inadequate intravenous fluid substitution during the procedure 1.5L during 60 minutes.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Read the detailed description

The specific aim of this prospective study is to collect serial hemoglobin levels intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous fluid substitution will change hemoglobin levels during the time the tourniquet is inflated (no blood loss).

The combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time.

Tubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet inflation and in PACU as well as POD 1.

Conditions: Anesthesia
Being tested: Blood drawn
Keywords: Blood management, Blood transfusion, Hemoglobin, Hypotensive Anesthesia, Total Knee Arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood drawnDiagnostic test
Hemoglobin and Hematocrit Levels

Study groups in NCT05340751
Study group	Role	What they receive
Anesthesia		hemoglobin Receives: Diagnostic Test: Blood drawn

What is being measured

The primary outcome is the main question the study is designed to answer.

The Hemoglobin (in g/dl) Levels
To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.
Measured: up to 48 hours after surgery
Hematocrit (g/dL) Levels
To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.
Measured: Up to 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20141 Sep 2014

First posted22 Apr 2022
Study start1 Jan 2014
Primary completion1 Sep 2014
Study completion1 Sep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnesthesiaStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05340751
Sponsor's protocol ID: 2015-081
Status last verified: Apr 2022
First submitted: 23 Nov 2018
Last updated: 26 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Data

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT05340751
Acronym / sponsor ID: 2015-081
Conditions: Anesthesia
Keywords: Blood management, Blood transfusion, Hemoglobin, Hypotensive Anesthesia, Total Knee Arthroplasty
Study type: Observational
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: 1 Jan 2014 (actual)
Primary completion: 1 Sep 2014 (actual)
Study completion: 1 Sep 2014 (actual)
First posted: 22 Apr 2022 (actual)
Results: Posted 26 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Anesthesia	–	Diagnostic Test: Blood drawnhemoglobin

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients scheduled for primary total knee arthroplasty who meet the qualifications will be consented prior to the surgery.

Key inclusion criteria (5 listed)

Non- inflammatory degenerative joint disease of the knee
Patients scheduled for unilateral primary total Knee arthroplasty
Age between 40 and 80 years
Hypotensive spinal-epidural anesthesia with systolic BP < 95 and diastolic BP < 65.
Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.

Key exclusion criteria (10 listed)

Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)
Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)
Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)
Congestive Heart Failure (at least one medication to treat congestive heart failure)
Coronary artery disease (s/p bypass, stent or AMI)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood drawnHemoglobin and Hematocrit Levels	Diagnostic test	Anesthesia

Primary outcome

The Hemoglobin (in g/dl) Levels
Time frame: up to 48 hours after surgery
To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.
Hematocrit (g/dL) Levels
Time frame: Up to 48 hours after surgery
To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anesthesia	35	32

Primary outcome: The Hemoglobin (in g/dl) Levels

Time frame: up to 48 hours after surgery. Mean (Standard Deviation). Unit: g/dl

Measure	Anesthesia n = 32
15 min	12.2 (1.2)
30 min	12.0 (1.2)
45 min	11.9 (1.595)
60 min	11.8 (1.3)
PACU stay	12.0 (1)
POD1 (24hr)	11.6 (1.2)
POD2 (48hr)	11.0 (1.3)

Primary outcome: Hematocrit (g/dL) Levels

Time frame: Up to 48 hours after surgery. Mean (Standard Deviation). Unit: g/dl

Measure	Anesthesia n = 32
15 min	36.8 (3.2)
30 min	36 (3.1)
45 min	35.4 (2.9)
60 min	34.7 (3.1)
PACU	35.1 (2.7)
POD1 (24hr)	35.3 (3.4)
POD (48hr)	32.6 (3.2)

Adverse events

Time frame: 2 days following surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anesthesia	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. Data

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RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Friedrich Boettner, MD principal investigator

Associate Professor of Orthopaedic Surgery

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Hemoglobin (in g/dl) Levels (time frame: up to 48 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.