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NCT05954832 Clinical Trial

A Study of Changes in Heart Function and Blood Flow in People Receiving Anesthesia

Anesthesia Clinical Trial

Official title:
Changes in Loading Conditions on Induction of General Anesthesia: Mechanisms of Post-Induction Hypotension (PIH)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05954832
Other study ID # 23-079
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 13, 2023
Est. completion date July 2027

Study information
Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact Anahita Dabo-Trubelja, MD
Phone 212-639-3279
Email daboa@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to understand changes in heart function (how the heart pumps blood) and blood flow in people who receive general anesthesia during surgery. The researchers are particularly interested in the heart function and blood flow changes in people who experience low blood pressure (hypotension) after receiving anesthesia.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date July 2027
Est. primary completion date July 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients = 18 years of age requiring general anesthesia for surgery - Intubation required for anesthetic management / surgery - Anticipated prep time before incision of 20 minutes - Baseline MAP >70mmHg Exclusion Criteria: - History of coronary artery disease - History of cardiac disease (e.g., HTN, arrythmias, valvular and structural abnormalities) - History of peripheral artery occlusive disease - Beta-blocker use - Anti-hypertensive medication use - Patients with epidural, spinal, paravertebral, serratus blocks preoperatively - Patients requiring rapid sequence induction (where intubation occurs concurrently with induction) - Emergency surgery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Echocardiography
Echocardiography and Clearsight BP measurements before, immediately after anesthesia induction and after intubation (for 20 min)

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center (All protocol activites) New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients with post-induction hypotension (PIH) summarize the distributions of the echocardiography parameter values (pre-load LVEDd(cm), after-load LVEDs(cm), other measures [e.g., contractility (EF %) and structural abnormalities]) across each timepoint among patients with and without PIH up to 20-mins after anesthesia induction.
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