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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.
The detailed description of clinical trial will be published by protocol later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAC group | Experimental | Electroacupuncture was performed for two consecutive days before surgery (2 daily 30-min sessions) by a licensed acupuncturist at 4.0 mA using an alternating frequency of 2 and 100 Hz (every 1.5 seconds) (LH-202, Huawei, Beijing, China). Acupoints included bilateral Yunmen (LU2), Zhongfu (LU1), Lieque (LU7), and Neiguan (PC6). On the day of surgery, electroacupuncture started upon the completion of a loading dose of dexmedetomidine, was suspended when CPB started (to avoid interference with electrocardiogram recording) and continued until the end of surgery. |
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| IGA group | No Intervention | Anesthesia was induced with propofol (2.0-3.5 μg/mL) by target control infusion and 0.3-0.5 μg/kg sufentanil. Tracheal intubation was facilitated by rocuronium (1.0 mg/kg). Anesthesia was maintained using isoflurane at 0.7-1.0 minimal alveolar concentration in a gas mixture of oxygen and air and remifentanil (0.05-0.2 μg·kg-1·min-1) by intravenous injection pump. Sufentanil dose was totally 2.5-4.0 μg/kg. Muscle relaxation was achieved using 1/3-1/4 of the induction dose every 40-60 min based on a train of four. Mechanical ventilation with 80% O2 in air was used. Tidal volume (7-8 mL/kg) and respiratory rate (10-12/min) were adjusted according to PETCO2 to achieve normal ventilation (PETCO2 35-45 mmHg). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative consumption of opioids | intraoperative consumption of sufentanil and remifentanil | end of the surgery, up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| time to drinking | The interval between the end of surgery and the first drink | through study completion, an average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| length of ICU stay | the length of time about transfer out of ICU after surgery | through study completion, an average of 12 days |
| The Vasoactive-inotropic Score | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianggang Song, MD | Acupuncture and Anesthesia Research Institute, Shanghai, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuguang Hospital of Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 201203 | China |
It is not yet known if there will be a plan to make IPD available. The results belong to the research team.
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We set a blind code in case patients have adverse effects. The random code and blind code will be conducted using opaque envelopes by a "third party" independent of the study. The envelopes will be sealed and shuffled, and the assignment records will not be disclosed until the end of the study. Trial participants, cardiothoracic surgeons, anesthesiologists, outcome assessors, and data analysts will be blinded to the treatment allocation to minimize potential sources of bias. Only the nurse of the anesthesiology department (having received specialized acupuncture training) will know the participants' group allocations. However, this nurse will not know any other information about the patients.
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| end of the surgery, up to 48 hours after surgery |