Propofol DosageNCT02705079
Values of Enhanced Monitoring by EEG Recording (Narcotrend) for Sedation in Endoscopic Ultrasound
An observational study of Propofol Dosage and Electroencephalography, run by Ruhr University of Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Propofol Dosage, Electroencephalography, Gender Identity
- What is being tested?
- EEG Monitoring
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Included are patients which is a , diagnostic or interventional endoscopic ultrasound under sedation with propofol.
Who may be able to join
- Age > 18
- Clinical indication for endoscopic ultrasound
Who cannot join
- ASA (American Society of Anesthesiologists) class V
- Known Pregnancy
- Emergency investigations
- Pre-existent hypotension (RRsys <90mmHg), bradycardia (HR <50 / min), hypoxia (SaO2 <90%)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Agness Karll Laatzen
Laatzen, 30880
Andrea Riphaus, PD MD, 0049 511 8208 ext. 2400, ariphaus@web.de
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Propofol Dosage, Electroencephalography, Gender Identity
- Being tested
- EEG Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG MonitoringOther
Value of EEG monitoring as adjunct to standard monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
mean recovery time after propofol sedation for Endoscopic ultrasound using the EEG recording EEG monitoring at stage D0 to D2
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Propofol DosageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Riphaus, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705079
- Sponsor's protocol ID
- 4440-12
- Status last verified
- Feb 2016
- First submitted
- 16 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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. doi: 10.1067/mge.2002.129603.
PubMed 12447291
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Values of Enhanced Monitoring by EEG Recording ( Narcotrend ) as an Adjunct to Standard Monitoring for Sedation in Endoscopic Ultrasonography
- ClinicalTrials.gov ID
- NCT02705079
- Acronym / sponsor ID
- 4440-12
- Conditions
- Propofol Dosage, Electroencephalography, Gender Identity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included are patients which is a , diagnostic or interventional endoscopic ultrasound under sedation with propofol.
Key inclusion criteria (2 listed)
- Age > 18
- Clinical indication for endoscopic ultrasound
Key exclusion criteria (4 listed)
- ASA (American Society of Anesthesiologists) class V
- Known Pregnancy
- Emergency investigations
- Pre-existent hypotension (RRsys <90mmHg), bradycardia (HR <50 / min), hypoxia (SaO2 <90%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG MonitoringValue of EEG monitoring as adjunct to standard monitoring | Other | – |
Primary outcome
mean recovery time after propofol sedation for Endoscopic ultrasound using the EEG recording EEG monitoring at stage D0 to D2
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Background: PubMed 12447291Wehrmann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Propofol Dosage and Electroencephalography, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean recovery time after propofol sedation for Endoscopic ultrasound using the EEG recording EEG monitoring at stage D0 to D2 (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.