Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index

NCT04562181 | Completed DMC

• 1 other identifier: 20200915
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia Monitor; Electroencephalography; Sleep

Outcome Measures

Primary Outcomes (1)

• qCON/qNOX indices of 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 Outcomes (1)

• qCON/qNOX indices data during operation

  from the beginning to the end of surgery

Study Arms (1)

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.

Other: Bispectral index and qCON/qNOX monitoring

Interventions

Bispectral index and qCON/qNOX monitoring OTHER

This study will characterise the bispectral index data and qCON/qNOX index data in 30 patients during the operation and first postoperative night

Interventions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

Wen-fei Tan

Shenyang, Liaoning, 110001, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 24, 2020
• Study Start: September 30, 2020
• Primary Completion: October 10, 2021
• Study Completion: November 5, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

CN (1)