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

NCT05011617 | Completed DMC

• 1 other identifier: 81603450
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Monitored Anesthesia Care; Cardiac Surgery; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• intraoperative consumption of opioids

  intraoperative consumption of sufentanil and remifentanil

  end of the surgery, up to 48 hours after surgery

Secondary Outcomes (1)

• time to drinking

  through study completion, an average of 24 hours

Other Outcomes (2)

• length of ICU stay

  through study completion, an average of 12 days

• The Vasoactive-inotropic Score

  end of the surgery, up to 48 hours after surgery

Study Arms (2)

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.

Device: Non-intubation and monitoring anesthesia care (MAC)

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).

Interventions

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.

MAC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) NYHA class II or less;
• \) expected aortic block time at ≤ 120 min;
• \) body mass index (BMI) between 18 and 30 kg/cm2.

You may not qualify if:

• \) systolic pulmonary blood pressure \> 70 mmHg;
• \) chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, or simplified airway risk index \> 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);
• \) coagulopathy (aPTT prolongation \> 10 seconds versus normal controls, PT prolongation \> 3 seconds versus normal controls, and INR \> 3.0).

Sponsors & Collaborators

• ShuGuang Hospital: lead

Study Sites (1)

Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

Study Officials

• Jianggang Song, MD

  Acupuncture and Anesthesia Research Institute, Shanghai, China

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of anesthesiology department of Shuguang Hospital

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 18, 2021
• Study Start: April 1, 2012
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)