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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05011617
Other study ID # 81603450
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2012
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source ShuGuang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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).

Study Design


Intervention

Device:
Non-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.

Locations

Country Name City State
China Shuguang Hospital of Shanghai University of Traditional Chinese Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
ShuGuang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other length of ICU stay the length of time about transfer out of ICU after surgery through study completion, an average of 12 days
Other 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. end of the surgery, up to 48 hours after surgery
Primary intraoperative consumption of opioids intraoperative consumption of sufentanil and remifentanil end of the surgery, up to 48 hours after surgery
Secondary time to drinking The interval between the end of surgery and the first drink through study completion, an average of 24 hours
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