Cardiac Surgery, Monitored Anesthesia Care, Postoperative Recovery
Conditions
Brief summary
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.
Detailed description
The detailed description of clinical trial will be published by protocol later.
Interventions
DEVICENon-intubation and monitoring anesthesia care (MAC)
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.
Sponsors
ShuGuang Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative consumption of opioids | end of the surgery, up to 48 hours after surgery | intraoperative consumption of sufentanil and remifentanil |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to drinking | through study completion, an average of 24 hours | The interval between the end of surgery and the first drink |
Other
| Measure | Time frame | Description |
|---|---|---|
| length of ICU stay | through study completion, an average of 12 days | the length of time about transfer out of ICU after surgery |
| The Vasoactive-inotropic Score | 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. |
Countries
China
Outcome results
None listed