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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04215289
Other study ID # IndonesiaUAnes 049
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 26, 2019
Est. completion date December 12, 2019

Study information

Verified date December 2019
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 12, 2019
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Qnox Values as a Predictor of Pain Response

Locations

Country Name City State
Indonesia Cipto Mangunkusumo General Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View Citation

Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Höcker 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. — View Citation

Jensen EW, Valencia JF, López A, Anglada T, Agustí 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( — View 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 Optiscopeā„¢ and the conventional laryngoscope. Korean J Anesthesiol. 2012 Aug;63(2):130-5. doi: 10.4 — View Citation

Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-7. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Qnox Values Observe the Qnox Values with Hemodynamic Changes to predict pain response 1 minutes