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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011617
• Other study ID #: 81603450
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Cardiac Surgery
• Monitored Anesthesia Care
• Postoperative Recovery

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