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Procedure
Echocardiography for Anesthesia Effects on Heart Function
N/A
Recruiting
Led By Anahita Dabo-Trubelja, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20-mins after anesthesia induction.
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how general anesthesia affects heart function and blood flow in people who experience low blood pressure during surgery.
Who is the study for?
This trial is for adults over 18 who need general anesthesia for surgery, with at least a 20-minute prep time before incision and normal blood pressure. It's not for those in emergency surgery, on anti-hypertensive or beta-blocker medications, or with a history of heart disease.
What is being tested?
The study uses echocardiography to observe how general anesthesia affects heart function and blood flow during surgery, especially when patients have low blood pressure after receiving anesthesia.
What are the potential side effects?
Since the intervention being studied is an observational technique (echocardiography), there are no direct side effects from it. However, risks may be associated with the underlying surgical procedure and use of anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 20-mins after anesthesia induction.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20-mins after anesthesia induction.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The proportion of patients with post-induction hypotension (PIH)
Side effects data
From 2024 Phase 3 trial • 218 Patients • NCT0055719370%
Alanine aminotransferase increased
58%
Mucositis oral
57%
Aspartate aminotransferase increased
57%
Febrile neutropenia
53%
Infections and infestations - Other, specify
48%
Neutrophil count decreased
33%
Hypokalemia
25%
Diarrhea
23%
White blood cell decreased
22%
Catheter related infection
22%
Anorexia
15%
Fever
15%
Platelet count decreased
13%
Dehydration
12%
Upper respiratory infection
12%
Skin infection
12%
Urinary tract infection
8%
Lung infection
8%
Skin ulceration
8%
Hypocalcemia
8%
Hyponatremia
7%
Alkaline phosphatase increased
7%
Anemia
7%
Weight loss
7%
Hyperglycemia
7%
Hypoglycemia
7%
Hypoxia
5%
Bronchial infection
5%
Enterocolitis infectious
5%
GGT increased
5%
Hypoalbuminemia
5%
Soft tissue infection
5%
Lymphocyte count decreased
5%
Skin and subcutaneous tissue disorders - Other, specify
3%
Sepsis
3%
Vomiting
3%
Pain
3%
Hypophosphatemia
3%
Pain of skin
3%
Oral pain
3%
Anaphylaxis
3%
Penile infection
3%
Erythema multiforme
2%
Blood and lymphatic system disorders - Other, specify
2%
Cardiac disorders - Other, specify
2%
Sinus tachycardia
2%
Irritability
2%
Scrotal infection
2%
Small intestine infection
2%
Fracture
2%
Wound complication
2%
Hyperkalemia
2%
Hypertriglyceridemia
2%
Generalized muscle weakness
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Penile pain
2%
Pharyngeal mucositis
2%
Pleural effusion
2%
Stridor
2%
Dry skin
2%
Surgical and medical procedures - Other, specify
2%
Hypotension
2%
Acute kidney injury
2%
Anal mucositis
2%
Esophagitis
2%
Gastritis
2%
Nausea
2%
Bladder infection
2%
Wound infection
2%
Investigations - Other, specify
2%
Peripheral motor neuropathy
2%
Peripheral sensory neuropathy
2%
Epistaxis
2%
Pneumonitis
2%
Pulmonary edema
2%
Respiratory failure
2%
Hypertension
2%
Enterocolitis
2%
Acidosis
2%
Renal and urinary disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Standard Risk MLL-G)
Arm B (IR/HR MLL-R Chemotherapy)
Arm C (Efficacy/ Dose Level 2)
Induction (All Patients)
Post Induction (Follow-up Only)
Arm C (Safety/ Dose Level 1)
Arm C (Safety/ Dose Level 2)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EchocardiographyExperimental Treatment1 Intervention
Patients participating in this study will undergo routine anesthetic and perioperative care with the addition of an echocardiography and Clearsight BP measurement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11580
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
General anesthesia involves the use of inhalational agents (such as sevoflurane) and intravenous agents (such as propofol) that depress the central nervous system, leading to loss of consciousness and sensation. These agents cause vasodilation and myocardial depression, resulting in decreased systemic vascular resistance and cardiac output, which can lead to hypotension.
This understanding is crucial for anesthesia patients because managing blood pressure is essential to ensure adequate organ perfusion and prevent complications during surgery.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,977 Previous Clinical Trials
599,477 Total Patients Enrolled
Anahita Dabo-Trubelja, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a fast process for being put on a breathing machine.I am 18 or older and need general anesthesia for surgery.I have a history of heart artery problems.I need emergency surgery.I have a history of heart disease.My surgery is expected to start 20 minutes after preparation.I have a history of blocked arteries in my limbs.I am taking beta-blocker medication.I am taking medication for high blood pressure.I will need a breathing tube for my surgery.I have had specific types of nerve blocks before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Echocardiography
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.