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

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

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.

Study Overview

• Status: Unknown
• Conditions: Propofol Dosage; Electroencephalography; Gender Identity
• Intervention / Treatment: Other: EEG Monitoring

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Laatzen, Germany, 30880
    • Recruiting
    • Klinikum Agness Karll Laatzen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Included are patients which is a , diagnostic or interventional endoscopic ultrasound under sedation with propofol.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean recovery time after propofol sedation for Endoscopic ultrasound using the EEG recording EEG monitoring at stage D0 to D2	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum

Publications and helpful links

General Publications

• Wehrmann T, Grotkamp J, Stergiou N, Riphaus A, Kluge A, Lembcke B, Schultz A. Electroencephalogram monitoring facilitates sedation with propofol for routine ERCP: a randomized, controlled trial. Gastrointest Endosc. 2002 Dec;56(6):817-24.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 4440-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No