Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index
Condition: Anesthesia Monitor; Electroencephalography; Sleep
Study type: Interventional

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. 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.
    

Intervention name(s): Bispectral index and qCON/qNOX monitoring
Intervention type(s): Other
Intervention description(s): This study will characterise the bispectral index data and qCON/qNOX index data in 30 patients during the operation and first postoperative night
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other