- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04215289
Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures
December 30, 2019 updated by: Adhrie Sugiarto, Indonesia University
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
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto mangunkusumo general hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult patients undergo general anesthesia procedure with tracheal intubation
Description
Inclusion Criteria:
- patient undergoes general anesthesia with tracheal intubation
- fasting as required for surgery
- physical ASA status I - II
- signing informed consent
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qnox Values
Time Frame: 1 minutes
|
Observe the Qnox Values with Hemodynamic Changes to predict pain response
|
1 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adhrie Sugiarto, MD, Indonesia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 26, 2019
Primary Completion (Actual)
December 10, 2019
Study Completion (Actual)
December 12, 2019
Study Registration Dates
First Submitted
December 30, 2019
First Submitted That Met QC Criteria
December 30, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 30, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IndonesiaUAnes 049
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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