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NCT Number: NCT05011617

Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass

Though Cardiac surgery under cardiopulmonary bypass (CPB) under epidural anesthesia in conscious patients is associated with increased risk of epidural hematoma. The investigators developed a monitored anesthesia care (MAC) platform for cardiac surgery under CPB. In the current prospective study, the investigators investigated the safety and effectiveness of the MAC platform versus intubated general anesthesia (IGA) in patients receiving elective open-heart surgery.

The study included adult patients who were scheduled to undergo open-heart surgery under CPB at Shuguang Hospital between April 2012 and December 2021. MAC consisted of local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil and electroacupuncture. MAC versus IGA was chosen by the patients. The investigators will investigate the safety and effectiveness of the MAC platform versus IGA in patients receiving elective open-heart surgery.

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Key information

Conditions

Monitored Anesthesia Care Cardiac Surgery Postoperative Recovery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

About this study

The detailed description of clinical trial will be published by protocol later.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1) NYHA class II or less;
  • 2) expected aortic block time at ≤ 120 min;
  • 3) body mass index (BMI) between 18 and 30 kg/cm2.

Exclusion criteria

  • 1) systolic pulmonary blood pressure > 70 mmHg;
  • 2) chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, or simplified airway risk index > 3;
  • 3) Child-Pugh grade B or C liver insufficiency or renal insufficiency (24-h creatinine clearance < 80 mL/min and blood urea nitrogen > 7.5 mmol/L);
  • 4) coagulopathy (aPTT prolongation > 10 seconds versus normal controls, PT prolongation > 3 seconds versus normal controls, and INR > 3.0).

Treatment and study plan

Non-intubation and monitoring anesthesia care (MAC)

Device

Non-intubation and monitoring anesthesia care (MAC) consisted of non-intubation technique, local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil, and electroacupuncture.

Primary outcomes

  1. intraoperative consumption of opioids

    Time frame: end of the surgery, up to 48 hours after surgery

    intraoperative consumption of sufentanil and remifentanil

Secondary outcomes

  1. time to drinking

    Time frame: through study completion, an average of 24 hours

    The interval between the end of surgery and the first drink

Other outcomes

  1. length of ICU stay

    Time frame: through study completion, an average of 12 days

    the length of time about transfer out of ICU after surgery

  2. The Vasoactive-inotropic Score

    Time frame: end of the surgery, up to 48 hours after surgery

    The vasoactive-inotropic score was used to evaluate the dose of various vasoactive drugs and calculated by the following formula: Vasoactive-inotropic score = dopamine (×1) + dobutamine (×1) + amrinone (×1) + milrinone (×15) + epinephrine (×100) + norepinephrine (×100) + isoprenaline (×100). The minimum value was 0 and the maximum values had no upper limit. The higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

ShuGuang Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2021
Registry last updated
May 10, 2022

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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