Monitored Anesthesia CareNCT05011617
Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass
A study testing Non-intubation and monitoring anesthesia care (MAC) in people with Monitored Anesthesia Care and Cardiac Surgery, run by ShuGuang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Monitored Anesthesia Care, Cardiac Surgery, Postoperative Recovery
- What is being tested?
- Non-intubation and monitoring anesthesia care (MAC)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2012to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203
About this study
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.
Read the detailed description
The detailed description of clinical trial will be published by protocol later.
- Being tested
- Non-intubation and monitoring anesthesia care (MAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative consumption of opioids
intraoperative consumption of sufentanil and remifentanil
Measured: end of the surgery, up to 48 hours after surgery
Secondary outcomes (1)
time to drinking
The interval between the end of surgery and the first drink
Measured: through study completion, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Apr 2012
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitored Anesthesia CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangang Song, ShuGuang Hospital
- Investigators
- Jianggang Song, MD, Study chair, Acupuncture and Anesthesia Research Institute, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011617
- Sponsor's protocol ID
- 81603450
- Status last verified
- May 2022
- First submitted
- 8 Aug 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet known if there will be a plan to make IPD available. The results belong to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05011617
- Acronym / sponsor ID
- 81603450
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC group | Experimental | Device: 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. |
| 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | MAC group |
Primary outcome
intraoperative consumption of opioids
Time frame: end of the surgery, up to 48 hours after surgery
intraoperative consumption of sufentanil and remifentanil
1 secondary outcome
time to drinking
Time frame: through study completion, an average of 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No. It is not yet known if there will be a plan to make IPD available. The results belong to the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianggang Song, MD study chair
Acupuncture and Anesthesia Research Institute, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-intubation and monitoring anesthesia care (MAC) in people with Monitored Anesthesia Care and Cardiac Surgery, run by ShuGuang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative consumption of opioids (time frame: end of the surgery, up to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.