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NCT04562181
Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index
NA trial testing Bispectral index and qCON/qNOX monitoring in Anesthesia Monitor in 30 participants. Completed in 5 November 2021.
10 October 2021
Quick facts
| Lead sponsor | China Medical University, China |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 30 September 2020 |
| Primary completion | 10 October 2021 |
| Estimated completion | 5 November 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Bispectral index and qCON/qNOX monitoring
Conditions studied
- Anesthesia Monitor — all drugs for Anesthesia Monitor →
- Electroencephalography — all drugs for Electroencephalography →
- Sleep — all drugs for Sleep →
Sponsor
China Medical University, China
Who can join
Adults 18 to 80, any sex, with Anesthesia Monitor or Electroencephalography. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04562181 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China Medical University, China
- Last refreshed: 9 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04562181.
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