Qnox Values as a Predictor of Pain ResponseNCT04215289
Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures
An observational study of Qnox Values as a Predictor of Pain Response, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Qnox Values as a Predictor of Pain Response
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 Nov 2019to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients undergo general anesthesia procedure with tracheal intubation
Who may be able to join
- patient undergoes general anesthesia with tracheal intubation
- fasting as required for surgery
- physical ASA status I - II
- signing informed consent
Who cannot join
- patient with difficult airway management
- patient with history of central nervous system abnormalities
- patient with history of hypersensitivity to drugs for general anesthesia
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Compatibility of Qnox Values With Hemodynamic Changes as a Predictor of Pain Response in Tracheal Intubation Procedures
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
- Keywords
- qNox Values, Hemodynamic changes, Predictor of pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Qnox Values
Observe the Qnox Values with Hemodynamic Changes to predict pain response
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start26 Nov 2019
- Primary completion10 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Qnox Values as a Predictor of Pain ResponseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhrie Sugiarto, Universitas Indonesia
- Investigators
- Adhrie Sugiarto, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215289
- Sponsor's protocol ID
- IndonesiaUAnes 049
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 18604519Ko 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 22949980Jensen 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 24995461Gruenewald 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 23471754Loeser 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compatibility of Qnox Values With Hemodynamic Changes as a Predictor of Pain Response in Tracheal Intubation Procedures
- ClinicalTrials.gov ID
- NCT04215289
- Acronym / sponsor ID
- IndonesiaUAnes 049
- Keywords
- qNox Values, Hemodynamic changes, Predictor of pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to analyze the compatibility of Qnox values with hemodynamic changes as a predictor of pain response in tracheal intubation procedures
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
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients undergo general anesthesia procedure with tracheal intubation
Key inclusion criteria (4 listed)
- patient undergoes general anesthesia with tracheal intubation
- fasting as required for surgery
- physical ASA status I - II
- signing informed consent
Key exclusion criteria (3 listed)
- patient with difficult airway management
- patient with history of central nervous system abnormalities
- patient with history of hypersensitivity to drugs for general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qnox Values
Time frame: 1 minutes
Observe the Qnox Values with Hemodynamic Changes to predict pain response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Results publication: PubMed 18604519Griesdale 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.
- Results publication: PubMed 22949980Ko 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.
- Results publication: PubMed 24995461Jensen 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.
- Results publication: PubMed 23471754Gruenewald 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.
- Results publication: PubMed 18583048Loeser 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adhrie Sugiarto, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Qnox Values as a Predictor of Pain Response, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qnox Values (time frame: 1 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215289, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.