Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604156
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-11
Brief Title:
Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of the Nociception Index qNOX in Painless Gastrointestinal Endoscopy a Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The monitoring of noxious stimuli plays a crucial role in anesthesia management particularly during general anesthesia In recent years new monitoring systems such as qCON and qNOX have been introduced into clinical practice to quantify the depth of sedation and analgesia These systems analyze electroencephalographic activity to more accurately assess patients39 stress responses and pain levels thereby assisting anesthesiologists in better controlling the dosages of sedative and analgesic medications and avoiding the risks associated with inadequate or excessive sedationThe high incidence of gastric and colorectal cancers has made gastrointestinal endoscopy an important diagnostic tool However traditional gastrointestinal endoscopy can cause discomfort and even fear in patients leading to a growing application of painless endoscopy Nevertheless painless gastrointestinal endoscopy may also be associated with certain complications particularly in elderly patients who may have multiple health issues that need consideration To ensure the safety and efficacy of painless gastrointestinal endoscopy it is essential to accurately control the depth of sedation and continuously monitor patients39 physiological responsesThis study aims to explore a safe and effective sedation depth protocol by integrating qCON and qNOX technologies with other clinical monitoring methods This approach not only helps alleviate patient discomfort but also enhances the quality and safety of the procedure ultimately improving the overall healthcare experience for patients
Detailed Description:
This study is a single-center prospective observational research It is divided into two parts the first part aims to explore and establish a stable and optimal depth of sedation during gastroscopy while the second part focuses on the same goal during colonoscopy The purpose of the study is to utilize qCON and qNOX technologies to assess patients39 sedation and analgesia status during painless gastrointestinal endoscopy combined with visual assessments cough reflex respiratory depression and limb movement and clinical physiological monitoring vital signs and pulse oximetry The goal is to prevent potential adverse events related to sedation and to explore and establish a stable and optimal depth of sedation for anesthesia Research method 110 patients undergoing painless gastroscopy and 110 patients undergoing painless colonoscopy were included During the procedures qCON and qNOX will be continuously monitoredand anesthesia induction drugs were given 15-25mgkg propofol 3-5 μ g sufentanil The injection speed of propofol is between 120s and 180s During the inspection pump propofol at 4-12mgkg h to achieve MOAAS 1 and there is no body movement reactionThe primary endpoint will be the quality of sedation during the passage of the gastroscope through the oropharynx and during the passage of the colonoscope through the anus Secondary endpoints will include qCON and qNOX measurements at different time points during the gastroscopy and colonoscopy hemodynamic changes and the incidence of adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None