Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index

November 5, 2021 updated by: Wen-fei Tan, China Medical University, China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Wen-fei Tan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ethnic Chinese;
  • Age: from 18 to 80 years old;
  • Hospitalized patients

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventions
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.
Other: Bispectral index and qCON/qNOX monitoring
This study will characterise the bispectral index data and qCON/qNOX index data in 30 patients during the operation and first postoperative night

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
on the first postoperative night

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
qCON/qNOX indices data during operation
Time Frame: from the beginning to the end of surgery
This study will characterise qCON/qNOX index data in 30 patients receiving gastrointestinal surgery under general anesthesia
from the beginning to the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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