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

Not Applicable

Completed

• Conditions: Monitored Anesthesia Care; Cardiac Surgery; Postoperative Recovery
• Interventions: Device: Non-intubation and monitoring anesthesia care (MAC)

• Registration Number: NCT05011617
• Lead Sponsor: ShuGuang Hospital

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.

Study Timeline

• Study Start: 2012-04-01
• Study First Submitted: 2021-08-08
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-18
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-07
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAC group	Non-intubation and monitoring anesthesia care (MAC)	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.

Primary Outcome Measures

Name	Time	Method
intraoperative consumption of opioids	end of the surgery, up to 48 hours after surgery	intraoperative consumption of sufentanil and remifentanil

Secondary Outcome Measures

Name	Time	Method
time to drinking	through study completion, an average of 24 hours	The interval between the end of surgery and the first drink

Trial Locations

Locations (1)

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China