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

NCT02705079 | Unknown

• 1 other identifier: 4440-12
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Propofol Dosage; Electroencephalography; Gender Identity

Outcome Measures

Primary Outcomes (1)

• mean recovery time after propofol sedation for Endoscopic ultrasound using the EEG recording EEG monitoring at stage D0 to D2

  Immediately after the procedure

Interventions

EEG Monitoring OTHER

Value of EEG monitoring as adjunct to standard monitoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 18
• Clinical indication for endoscopic ultrasound

You may not qualify if:

• ASA (American Society of Anesthesiologists) class V
• Known Pregnancy
• Emergency investigations
• Pre-existent hypotension (RRsys \<90mmHg), bradycardia (HR \<50 / min), hypoxia (SaO2 \<90%)

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Klinikum Agness Karll Laatzen

Laatzen, 30880, Germany

RECRUITING

Related Publications (1)

• 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. doi: 10.1067/mge.2002.129603.

  PMID: 12447291 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Andrea Riphaus

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 10, 2016
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-02

Locations

DE (1)