What side effects are associated with this type of intervention?

General anesthesia can lead to several side effects, particularly affecting cardiovascular function. Common side effects include hypotension (low blood pressure), bradycardia (slow heart rate), and sedation. In some cases, prolonged neuromuscular weakness and respiratory complications such as bronchoconstriction may occur. These effects necessitate careful monitoring, especially in patients with pre-existing conditions.

What prior FDA approvals exist?

FDA-approved treatments for managing cardiovascular function and hypotension during anesthesia include esmolol, an ultra-short-acting beta-blocker, and vasopressors like norepinephrine and vasopressin. These drugs are used to maintain hemodynamic stability and manage hypotension in patients undergoing general anesthesia.

What other types of research exist?

Promising alternatives to general anesthesia that minimize cardiovascular effects, including hypotension, include neuraxial anesthesia (epidural or spinal anesthesia) and regional anesthesia (e.g., brachial plexus block). Sedation techniques using agents like midazolam or dexmedetomidine, which offer a more stable hemodynamic profile, are also viable options.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20-mins after anesthesia induction. for reporting.

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 • NCT00557193

70%

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

Lung infection

Skin ulceration

Hypocalcemia

Hyponatremia

Alkaline phosphatase increased

Anemia

Weight loss

Hyperglycemia

Hypoglycemia

Hypoxia

Bronchial infection

Enterocolitis infectious

GGT increased

Hypoalbuminemia

Soft tissue infection

Lymphocyte count decreased

Skin and subcutaneous tissue disorders - Other, specify

Sepsis

Vomiting

Pain

Hypophosphatemia

Pain of skin

Oral pain

Anaphylaxis

Penile infection

Erythema multiforme

Blood and lymphatic system disorders - Other, specify

Cardiac disorders - Other, specify

Sinus tachycardia

Irritability

Scrotal infection

Small intestine infection

Fracture

Wound complication

Hyperkalemia

Hypertriglyceridemia

Generalized muscle weakness

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Penile pain

Pharyngeal mucositis

Pleural effusion

Stridor

Dry skin

Surgical and medical procedures - Other, specify

Hypotension

Acute kidney injury

Anal mucositis

Esophagitis

Gastritis

Nausea

Bladder infection

Wound infection

Investigations - Other, specify

Peripheral motor neuropathy

Peripheral sensory neuropathy

Epistaxis

Pneumonitis

Pulmonary edema

Respiratory failure

Hypertension

Enterocolitis

Acidosis

Renal and urinary disorders - Other, specify

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.