Values of Enhanced Monitoring by EEG Recording (Narcotrend) for Sedation in Endoscopic Ultrasound

Electroencephalography Clinical Trial

Official title:

Values of Enhanced Monitoring by EEG Recording ( Narcotrend ) as an Adjunct to Standard Monitoring for Sedation in Endoscopic Ultrasonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705079
• Other study ID #: 4440-12
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2016
• Last updated: March 9, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethic committee
• Study type: Observational

Clinical Trial Summary

Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally recommended under sedation and also carried out in practice here.

The vital signs monitoring to avoid complications is dictated by current national guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In patients with severe heart disease an ECG recording should be used additionally. Moreover, the guidelines require that the sedation is clinically monitored continuously to avoid an unwanted anesthetic stage.

Such evaluation, however, is often difficult under clinical conditions and even counterproductive, since a constant response and tactile stimulation of the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex intervention. However, clinical most relevant aspect is the avoidance of unrecognized transition of patients from the stage of deep sedation in an anesthetic stage.

Current recommendations do not take into account new study results from a gender perspective, which showed that women and men need a different wake-up time using the EEG derivation means by using teh Narcotrend after total intravenous anesthesia, which may be due to different total doses of sedatives needed. However, the research group has been demonstrated in a previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time by a lower dose of the administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde cholangiopancreatography-(ERCP).

In the presented study the investigators evaluate the extent of gender differences in the wake-up time after sedation with propofol during endoscopic ultrasound when using EEG monitoring.

Description:

Endoscopic examinations and particularly long-lasting interventions can be uncomfortable for patients. Pain and vasovagal reactions are common. Therefore, the implementation is generally recommended under sedation and also carried out in practice here.

In interventional and longer lasting interventions (for example, endoscopic ultrasonography, ERCP) as opposed to purely diagnostic examinations is often deep sedation.Use of propofol in terms of sedation efficacy and the wake-up time or quality is superior to the use of benzodiazepines (plus opiates), while patient safety is the same.

The vital signs monitoring to avoid complications is dictated by current national guidelines. Necessary measures of monitoring include pulse oximetry and blood pressure measurements. In patients with severe heart disease an ECG recording should be used additionally. Moreover, the guidelines require that the sedation is clinically monitored continuously to avoid an unwanted anesthetic stage.

Such evaluation, however, is often difficult under clinical conditions and even counterproductive, since a constant response and tactile stimulation of the patient (to check clinically the depth level of sedation ), interrupts endoscopic complex intervention. However, clinical most relevant aspect is the avoidance of unrecognized transition of patients from the stage of deep sedation in an anesthetic stage.

Current recommendations do not take into account new study results from a gender perspective, which showed that women and men need a different wake-up time using the EEG derivation means by using the Narcotrend after total intravenous anesthesia, which may be due to different total doses of sedatives needed. However, the research group has been demonstrated in a previous study that most likely caused by the use of EEG monitoring (Narcotrend) an effective adaptation of sedation, in particular a more rapid recovery time by a lower dose of the administered sedative for a continuous sedation stage D0-D2 endoscopic retrograde cholangiopancreatography-(ERCP). In the presented study the investigators evaluate the extent of gender differences in the wake-up time after sedation with propofol during when using EEG monitoring.

Included are patients who undergo endoscopic ultrasonography, which is performed under sedation with propofol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 18

• Clinical indication for endoscopic ultrasound

Exclusion Criteria:

• ASA (American Society of Anesthesiologists) class V

• Known Pregnancy

• Emergency investigations

• Pre-existent hypotension (RRsys <90mmHg), bradycardia (HR <50 / min), hypoxia (SaO2 <90%)

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Electroencephalography
• Gender Identity
• Propofol Dosage

Intervention

Other:
• EEG Monitoring
Value of EEG monitoring as adjunct to standard monitoring

Locations

Country	Name	City	State
Germany	Klinikum Agness Karll Laatzen	Laatzen

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Riphaus A, Wehrmann T, Weber B et al. S3-guidelines-sedation in gastrointestinal endoscopy. Z Gastroenterol. 2008; 46:1298-330. Haensch K, Schultz A, Krauß T et al. Women need more Propofol than men during EEG- monitored total intravenous anaesthesia. Biomed Tech 2009;54: 76- 82 Wehrmann T, Grotkamp J, Stergiou N, Riphaus A et al. Electroencephalogram monitoring facilitates seation with propofol for routine ERCP: a randomized, controlled trial. Gastrointest Endosc (2002); 56: 817- 24

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean recovery time after propofol sedation for Endoscopic ultrasound using the EEG recording EEG monitoring at stage D0 to D2		Immediately after the procedure	No