Anesthesia MonitorNCT04562181
Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index
A study testing Bispectral index and qCON/qNOX monitoring in people with Anesthesia Monitor and Electroencephalography, run by China Medical University, China at 1 site in China.
Trial summary
The first objective of this work is to compare the performances of three electroencephalogram based indices, the qCON index, the qNOX index and the bispectral index (BIS), in patients receiving gastrointestinal surgery during first postoperative night. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia Monitor, Electroencephalography, Sleep
- What is being tested?
- Bispectral index and qCON/qNOX monitoring
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2020to 5 Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnic Chinese;
- Age: from 18 to 80 years old;
- Hospitalized patients
Who cannot join
- Cognitive difficulties
- Mental diseases
- Without an informed consent
- Inability to cooperate with the researcher's requirements
- Deprivation of the human right by an administrative or juridical entity
- Ongoing participation or participation in another study within 1 month
- Night surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index in Detecting Hypnotic and Nociception Level During and After General Anesthesia in Gastrointestinal Surgery Patients
The first objective of this work is to compare the performances of three electroencephalogram based indices, the qCON index, the qNOX index and the bispectral index (BIS), in patients receiving gastrointestinal surgery during first postoperative night. Secondly, their behaviors under general anesthesia are also pointed out.
The qCON and qNOX indices are implemented in an Angel 6000 monitor (WellHealth Medical Co Ltd., Shenzhen, China), and BIS indices are recorded in a BIS monitor (Aspect Medical Systems, Norwood, MA, USA).
Data will be obtained from 30 patients scheduled for selective surgery undergoing general anesthesia with a combination of propofol, sufentanil and cis-atracurium in the first Hospital of China Medical University. The values of qCON, qNOX and BIS were statistically compared. The qCON, qNOX indices are recorded together with BIS during the whole operation period (Awake- Anesthesia-Recovery stages), as well as during the first night postoperatively (from 8:00pm to 06:00am). The values of qCON, qNOX and BIS were statistically compared. The Consistency evaluation will be conducted between qCON/qNOX and BIS.
Read the detailed description
This study was approved by the ethics committee of China Medical University. The study will be carried out in the 1st Hospital of China Medical University. Thirty patients scheduled for selective gastrointestinal surgery undergoing general anesthesia will be enrolled. There are two steps in this study: In step1, The qCON and qNOX indices will be continuously recorded throughout the whole surgery, using a Angel-6000 monitor (WellHealth Medical Co Ltd., Shenzhen, China). Meanwhile, the bispectral index (BIS) will be recorded using Aspect BIS monitor (Aspect Medical Systems, Norwood, MA, USA) in the same patient in order to compare with qCON and qNOX.
The general anesthesia protocol is as following: Anesthesia will be induced with bolus infusion of propofol, sufentanil and cis-atracurium intravenously. The patients will be intubated subsequently. TOF (T4/T1) value will be observed throughout using muscle relaxation monitoring (GE healthcare, USA). Anesthesia are maintained with a combination of sevoflurane, propofol, sufentanil and cis-atracurium. Dosage of the anesthetics will be adjusted according to the BIS value and hemodynamics fluctuating. Anti-emetic and opioids will be routinely administrated prior to abdominal closure. Neostigmine will be administrated for reversing the residual neuromuscular blockade after the patient get his breath. Tracheal extubating is indicated by a TOF value above 70% in addition to other physical signs. The qCON, qNOX and BIS indices will be continuously recorded before anesthesia induction (fully awake), during the operation (sleep) and after the operation (fully recovery). The dosage of propofol, sufentanil and cis-atracurium used in the operation are also recorded.
In step2, all these three electroencephalogram-based indices are collected again at the 1st postoperative night. The Angel-6000 and Aspect BIS monitor will be placed again to the identical patient who have received the operation on the daytime. Data collecting period is from 8:00 pm to 6:00 am the next day. Sleep was defined as the duration of BIS value below 80 in the 10 hours of monitoring (from 8:00pm to 6:00am).
If there are specific requirements for management with regards to postoperative pain or any other anesthesia related complications, name and the dosage of the treatments will also be recorded.
- Conditions
- Anesthesia Monitor, Electroencephalography, Sleep
- Being tested
- Bispectral index and qCON/qNOX monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index and qCON/qNOX monitoringOther
This study will characterise the bispectral index data and qCON/qNOX index data in 30 patients during the operation and first postoperative night
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Experimental | Anesthesia will be induced with bolus infusion using propofol, sufentanil and cis-atracurium intravenously. The patients will be intubated subsequently. TOF (T4/T1) will be calculated continuously using muscle relaxation monitoring. Anesthesia are maintained with a combination of sevoflurane, propofol, sufentanil and cis-atracurium. Anti-emetic and opioids will be routinely administrated prior to abdominal closure. Neostigmine will be administrated for reversing the residual neuromuscular blockade after the patient get his breath. Tracheal extubating is indicated by a TOF value above 70% in addition to other physical signs. Receives: Other: Bispectral index and qCON/qNOX monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
qCON/qNOX indices of the first postoperative night
This study will characterise the qCON/qNOX index data in 30 patients during first postoperative night
Measured: on the first postoperative night
Secondary outcomes (1)
qCON/qNOX indices data during operation
This study will characterise qCON/qNOX index data in 30 patients receiving gastrointestinal surgery under general anesthesia
Measured: from the beginning to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start30 Sep 2020
- Primary completion10 Oct 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia MonitorStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562181
- Sponsor's protocol ID
- 20200915
- Status last verified
- Nov 2021
- First submitted
- 14 Sep 2020
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index in Detecting Hypnotic and Nociception Level During and After General Anesthesia in Gastrointestinal Surgery Patients
- ClinicalTrials.gov ID
- NCT04562181
- Acronym / sponsor ID
- 20200915
- Conditions
- Anesthesia Monitor, Electroencephalography, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 24 Sep 2020 (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.
The first objective of this work is to compare the performances of three electroencephalogram based indices, the qCON index, the qNOX index and the bispectral index (BIS), in patients receiving gastrointestinal surgery during first postoperative night. Secondly, their behaviors under general anesthesia are also pointed out.
The qCON and qNOX indices are implemented in an Angel 6000 monitor (WellHealth Medical Co Ltd., Shenzhen, China), and BIS indices are recorded in a BIS monitor (Aspect Medical Systems, Norwood, MA, USA).
Data will be obtained from 30 patients scheduled for selective surgery undergoing general anesthesia with a combination of propofol, sufentanil and cis-atracurium in the first Hospital of China Medical University. The values of qCON, qNOX and BIS were statistically compared. The qCON, qNOX indices are recorded together with BIS during the whole operation period (Awake- Anesthesia-Recovery stages), as well as during the first night postoperatively (from 8:00pm to 06:00am). The values of qCON, qNOX and BIS were statistically compared. The Consistency evaluation will be conducted between qCON/qNOX and BIS.
Detailed description
This study was approved by the ethics committee of China Medical University. The study will be carried out in the 1st Hospital of China Medical University. Thirty patients scheduled for selective gastrointestinal surgery undergoing general anesthesia will be enrolled. There are two steps in this study: In step1, The qCON and qNOX indices will be continuously recorded throughout the whole surgery, using a Angel-6000 monitor (WellHealth Medical Co Ltd., Shenzhen, China). Meanwhile, the bispectral index (BIS) will be recorded using Aspect BIS monitor (Aspect Medical Systems, Norwood, MA, USA) in the same patient in order to compare with qCON and qNOX.
The general anesthesia protocol is as following: Anesthesia will be induced with bolus infusion of propofol, sufentanil and cis-atracurium intravenously. The patients will be intubated subsequently. TOF (T4/T1) value will be observed throughout using muscle relaxation monitoring (GE healthcare, USA). Anesthesia are maintained with a combination of sevoflurane, propofol, sufentanil and cis-atracurium. Dosage of the anesthetics will be adjusted according to the BIS value and hemodynamics fluctuating. Anti-emetic and opioids will be routinely administrated prior to abdominal closure. Neostigmine will be administrated for reversing the residual neuromuscular blockade after the patient get his breath. Tracheal extubating is indicated by a TOF value above 70% in addition to other physical signs. The qCON, qNOX and BIS indices will be continuously recorded before anesthesia induction (fully awake), during the operation (sleep) and after the operation (fully recovery). The dosage of propofol, sufentanil and cis-atracurium used in the operation are also recorded.
In step2, all these three electroencephalogram-based indices are collected again at the 1st postoperative night. The Angel-6000 and Aspect BIS monitor will be placed again to the identical patient who have received the operation on the daytime. Data collecting period is from 8:00 pm to 6:00 am the next day. Sleep was defined as the duration of BIS value below 80 in the 10 hours of monitoring (from 8:00pm to 6:00am).
If there are specific requirements for management with regards to postoperative pain or any other anesthesia related complications, name and the dosage of the treatments will also be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions | Experimental | Other: Bispectral index and qCON/qNOX monitoringAnesthesia will be induced with bolus infusion using propofol, sufentanil and cis-atracurium intravenously. The patients will be intubated subsequently. TOF (T4/T1) will be calculated continuously using muscle relaxation monitoring. Anesthesia are maintained with a combination of sevoflurane, propofol, sufentanil and cis-atracurium. Anti-emetic and opioids will be routinely administrated prior to abdominal closure. Neostigmine will be administrated for reversing the residual neuromuscular blockade after the patient get his breath. Tracheal extubating is indicated by a TOF value above 70% in addition to other physical signs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ethnic Chinese;
- Age: from 18 to 80 years old;
- Hospitalized patients
Key exclusion criteria (7 listed)
- Cognitive difficulties
- Mental diseases
- Without an informed consent
- Inability to cooperate with the researcher's requirements
- Deprivation of the human right by an administrative or juridical entity
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 |
|---|---|---|
| Bispectral index and qCON/qNOX monitoringThis study will characterise the bispectral index data and qCON/qNOX index data in 30 patients during the operation and first postoperative night | Other | Interventions |
Primary outcome
qCON/qNOX indices of the first postoperative night
Time frame: on the first postoperative night
This study will characterise the qCON/qNOX index data in 30 patients during first postoperative night
1 secondary outcome
qCON/qNOX indices data during operation
Time frame: from the beginning to the end of surgery
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 9 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index and qCON/qNOX monitoring in people with Anesthesia Monitor and Electroencephalography, run by China Medical University, China 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 7 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 9 Nov 2021. 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?
qCON/qNOX indices of the first postoperative night (time frame: on the first postoperative night). 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 9 Nov 2021.