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Completed

NCT Number: NCT06397092

Anesthetic Management for TA-BSM in HOCM

To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Wuhan, Hubei, 430030, China

About this study

Hypertrophic obstructive cardiomyopathy is an inherited cardiomyopathy. Such patients have significantly reduced mobility and quality of life, and are prone to sudden death in severe cases. According to conservative estimates, there are about 2 to 5 million patients with hypertrophic heart disease in China, and about 15 to 20 million patients in the world, which seriously threatens human health. The traditional surgical treatment is partial ventricular septal myectomy through thoracotomy, which is traumatic and difficult, with poor efficacy and high operative mortality in hospitals with little experience.

In order to solve this problem, professor Wei's team invented and developed a beating-heart myectomy device, and established the first transapical beating-heart septal myectomy (TA-BSM) with the aid of this device through the apical minimally invasive incision under the guidance of esophageal ultrasound. With the help of echocardiography, the position of the rotator can be monitored in real time, and the angle and thickness of the rotator can be determined to ensure the safe removal of the hypertrophic ventricular septum, so as to solve the problem of left ventricular outflow tract obstruction.

The team firstly completed 47 clinical trials from April to September 2022, with a surgical success rate of 97.9%. At 3-month follow-up, the median maximum pressure gradient of left ventricular outflow tract decreased from perioperational 86 mmHg to postoperational 19 mmHg , and 45 participants (95.7%) had complete remission of mitral regurgitation. All patients showed significant improvement or even disappearance of symptoms, and exercise capacity and quality of life were significantly improved.

Since TA-BSM is a new surgical method, there is no unified standard for anesthesia management and lack of evidence-based evidence. Therefore, the aim of this study is to retrospectively analyze the preoperative, intraoperative and postoperative anesthetic management of participants with hypertrophic cardiomyopathy undergoing TA-BSM, so as to provide clinical basis for formulating reasonable and standardized perioperative anesthesia programs for these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with hypertrophic cardiomyopathy
  • American Society of Anesthesiologists (ASA) physical status classification I-III
  • Undergoing TA-BSM

Exclusion criteria

  • Cardiopulmonary bypass was used to assist the surgery.

Treatment and study plan

transapical beating-heart septal myectomy

Procedure

The patients with hypertrophic cardiomyopathy undergoing TA-BSM

Primary outcomes

  1. Perioperative information 1

    Time frame: During surgery, when use isoproterenol to provocate

    Heart reat

  2. Perioperative information 2

    Time frame: During surgery, when use isoproterenol to provocate

    Systolic arterial blood pressure

  3. Perioperative information 3

    Time frame: During surgery, when use isoproterenol to provocate

    Diastolic arterial blood pressure

  4. Perioperative information 4

    Time frame: During surgery, when use isoproterenol to provocate

    Mean arterial blood pressure

  5. Perioperative information 5

    Time frame: Immediately after the surgery

    The type of tracheal tube

  6. Perioperative information 6

    Time frame: Immediately after the surgery

    The usage of anaesthetic drugs

  7. Perioperative information 7

    Time frame: Immediately after the surgery

    The usage of cardiovascular drugs

  8. Perioperative information 8

    Time frame: Immediately after the surgery

    Intraoperative infusion volume

  9. Perioperative information 9

    Time frame: Immediately after the surgery

    Blood transfusion volume

  10. Perioperative information 10

    Time frame: Immediately after the surgery

    Blood loss

Secondary outcomes

  1. Postoperative information 1

    Time frame: Postoperative in 30 days

    Extubation time,

  2. Postoperative information 2

    Time frame: Postoperative in 30 days

    Postoperative pain score: Pain score evaluation was performed after surgery ( 0-10 stands for the degree of the pain, 0 for painless and 10 for twinge).

  3. Postoperative information 3

    Time frame: Postoperative in 30 days

    The usagen of analgesic drug

  4. Postoperative information 4

    Time frame: Postoperative in 30 days

    Postoperative complications

  5. Laboratory tests information 1

    Time frame: 7 days before surgery and 3 days after surgery

    The changes of hemoglobin (Hb)

  6. Laboratory tests information 2

    Time frame: 7 days before surgery and 3 days after surgery

    the changes of creatinine (Cr)

  7. Laboratory tests information 3

    Time frame: 7 days before surgery and 3 days after surgery

    the changes of albumin (Alb)

  8. Laboratory tests information 4

    Time frame: 7 days before surgery and 3 days after surgery

    the changes of cardiac uhrasonography findings

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM):A Retrospective Analysis

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 2, 2024
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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