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CompletedNCT04215289Updated Jan 2, 2020

Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures

An observational study in Qnox Values as a Predictor of Pain Response, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Indonesia University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
54
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study aimed to analyze the compatibility of Qnox values with hemodynamic changes as a predictor of pain response in tracheal intubation procedures

Read the detailed description

Fifty-four patients were given informed consent before enrolling the study. Non-invasive blood pressure monitor, electrocardiogram, pulse oxymetry, and Conox probe were set on the subjects in the operation room. Baseline hemodynamic is noted. General anesthesia induction was done by fentanyl 2.5 mcg/kg and propofol 2 mg/kg. Endotracheal tube intubation was facilitated with rocuronium 0.8 mg/kg as muscle relaxant. qNox values right before intubation and after intubation is noted, as well as hemodynamic changes in one minute after intubation

02

Conditions studied

  • Qnox Values as a Predictor of Pain Response

Keywords

  • qNox Values, Hemodynamic changes, Predictor of pain
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients undergo general anesthesia procedure with tracheal intubation

Inclusion criteria

  • patient undergoes general anesthesia with tracheal intubation
  • fasting as required for surgery
  • physical ASA status I - II
  • signing informed consent

Exclusion criteria

Exclusion Criteria:

  • patient with difficult airway management
  • patient with history of central nervous system abnormalities
  • patient with history of hypersensitivity to drugs for general anesthesia
05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
54 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Qnox Values

    Observe the Qnox Values with Hemodynamic Changes to predict pain response

    Time frame: 1 minutes

07

Study locations

1 site
  • Cipto Mangunkusumo General Hospital
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
08

References and documents

Publications

  • Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5. PubMed 18604519 ↗
  • Ko DD, Kang H, Yang SY, Shin HY, Baek CW, Jung YH, Woo YC, Kim JY, Koo GH, Kim SD. A comparison of hemodynamic changes after endotracheal intubation by the Optiscope and the conventional laryngoscope. Korean J Anesthesiol. 2012 Aug;63(2):130-5. doi: 10.4097/kjae.2012.63.2.130. Epub 2012 Aug 14. PubMed 22949980 ↗
  • Jensen EW, Valencia JF, Lopez A, Anglada T, Agusti M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4. PubMed 24995461 ↗
  • Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6. PubMed 23471754 ↗
  • Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available. PubMed 18583048 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04215289
Lead sponsor
Indonesia University
Responsible party
Adhrie Sugiarto (MD, Indonesia University) — Principal investigator
First posted
Jan 2, 2020
Start date
Nov 26, 2019
Primary completion
Dec 10, 2019
Completion
Dec 12, 2019
Last update
Jan 2, 2020

Study contacts

Adhrie Sugiarto, MD
principal investigator · Indonesia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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