Clinical trial NCT04215289: Compatibility of Qnox Values With Hemodynamic Changes in Tracheal Intubation Procedures
Official title: Compatibility of Qnox Values With Hemodynamic Changes as a Predictor of Pain Response in Tracheal Intubation Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Qnox Values as a Predictor of Pain Response
Keywords: qNox Values, Hemodynamic changes, Predictor of pain
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients undergo general anesthesia procedure with tracheal intubation

Brief summary: 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

Eligibility criteria: 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

Primary outcomes:
measure: Qnox Values
timeFrame: 1 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Adhrie Sugiarto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.