PainMOGADANCT03303651
Monitor-Guided Analgesia During General Anesthesia - Part I
A study testing Opioid administration in intervention groups in people with Pain and Pain, Postoperative, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid analgesia during general anesthesia. To date no standard-monitoring device exists to specifically reflect the analgesic component of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Pain, Postoperative, Nociceptive Pain
- What is being tested?
- Opioid administration in intervention groups
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2017to 26 Jan 2018
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radical open abdominal prostatectomy scheduled in the operation theater where the study is conducted
- > 18 years
Who cannot join
- Chronic pain therapy, e.g. out-of-hospital opioid therapy
- Beta blocker and digitalis therapy
- Eye disease with affection of pupil reactivity
- Pacemaker therapy
- Higher degrees of cardiac arrhythmias, e.g. atrial fibrillation
- Pre-operative medication with steroids
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Hamburg, 20257
About this study
Official title: Investigation of the Effect of Opioid Titration Guided by Analgesia Indices During General Anesthesia
This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid analgesia during general anesthesia. To date no standard-monitoring device exists to specifically reflect the analgesic component of general anesthesia. Quality and safety of general anesthesia are of major clinical importance and should be improved by limiting the opioid analgesic's dosage to the minimum amount needed. The study compares the effects of monitoring nociception during general anesthesia with different innovative techniques in comparison to routine clinical practice.
Read the detailed description
This prospective randomized clinical study aims to investigate the effects of a monitor-guided opioid analgesia during general anesthesia by different monitoring systems in comparison to routine clinical practice. Many surgical procedures require general anesthesia. The main components of general anesthesia are hypnosis and analgesia, and anesthesiologists usually combine a hypnotic drug with an opioid analgesic.
Until today, however, there is no standard-monitoring of nociception to specifically reflect the analgesic component of general anesthesia. In clinical practice the opioid dosage is chosen by clinical judgment of the attending anesthesiologist based upon changes of heart rate, blood pressure, pupil size, lacrimation and sweating of the patient.
On the one hand, underdosage of opioids can cause nociception leading to an increased sympathetic tone, increase of plasma levels of stress hormones, nociceptive movements as well as increase postoperative pain. On the other hand, overdosage of opioids can lead to drug side effects such as nausea and vomiting, hemodynamic instability, an increase in recovery times, immunosuppression and an increase in postoperative pain by opioid-induced-hyperalgesia. Quality and safety of general anesthesia are of major clinical importance and can be improved by limiting the administration of opioid analgesics to the optimal individual dose needed. In the last years, different analgesia monitoring devices have been developed for monitoring nociception. The present study evaluates the effects of the administration of opioids during general anesthesia guided by three different monitoring systems in comparison to routine clinical practice. After institutional approval by the Ethics committee of the Medical Board of the City of Hamburg, Germany and obtaining patients' written informed consent the investigators randomize elective patients with major abdominal surgery for open radical prostatectomy into one of four treatment groups.
- Conditions
- Pain, Pain, Postoperative, Nociceptive Pain, Opioid Use, Analgesia
- Being tested
- Opioid administration in intervention groups, Opioid administration in control group
- Keywords
- Analgesia, Monitoring, Opioid, Sufentanil, Sevoflurane
- Medical subject headings
- Pain, Pain, Postoperative, Nociceptive Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid administration in intervention groupsProcedure or surgery
Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms.
Opioid administration in control groupProcedure or surgery
Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group.
| Study group | Role | What they receive |
|---|---|---|
| PPI (Pain Pupillary Index) | Experimental | Opioid administration guided by Pain Pupillary Index (PPI) derived from Videopupillometry performed with the device AlgiScan manufactured by IDMed, Marseille, France. The device measures the degree of pupillary reflex dilation (PRD) following an electric nociceptive stimulation. It automatically increases the intensity of the electric stimulation from 10 to 60 milliampere depending on the degree of PRD and afterwards displays the PPI. The numerical index ranges from 0 to 10. A low PPI score indicates a deep analgesia, a high PPI score indicates an insufficient or light analgesia. A PPI score of 2 or 3 is supposed to represent an optimal level of analgesia according to the manufacturer. 5 µg sufentanil will be administered every 5 minutes if PPI score is calculated more than 3. Receives: Procedure: Opioid administration in intervention groups |
| SPI (Surgical Pleth Index) | Experimental | Opioid administration (sufentanil) guided by by Surgical Pleth Index (SPI) derived from photoplethysmography performed by the device CARESCAPE B650 Patient Monitor from the manufacturer GE (General Electrics) Healthcare, Helsinki, Finland. Included in the monitoring system is a software that continuously calculates the SPI from normalized heart rate and pulse wave amplitude derived from finger plethysmography. The numerical index ranges between 0 (low sympathetic tone) and 100 (high sympathetic tone). A SPI score between 20 and 50 has been proposed as the target range to guide analgesics (15 - 17). 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50. Receives: Procedure: Opioid administration in intervention groups |
| NOL (Nociception Level) | Experimental | Opioid administration (sufentanil) guided by Nociception Level (NOL) derived from finger photoplethysmography performed with the analgesia monitoring device PMD200 manufactured by Medasense, Ramat Gan, Israel. The device continuously calculates the NOL with a multi-parametric approach from pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, skin conductance fluctuations, skin temperature and finger motion. The composite algorithm of the device analyses the data and the numerical index NOL is presented on a scale from 0 (no pain) to 100 (extreme pain) (18). A NOL score between 10 and 25 has been proposed as the target range to guide analgesics. 5 µg Sufentanil will be administered every 5 minutes if NOL score is calculated more than 25. Receives: Procedure: Opioid administration in intervention groups |
| Control | Active comparator | Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation and sweating of the patient. Receives: Procedure: Opioid administration in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid consumption
Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.
Measured: 1 day
Secondary outcomes (6)
Time to extubation
Postoperative recovery time: Time interval between end of operation and tracheal extubation of the patient.
Measured: 1 day
Time to fit-for-discharge
Postoperative recovery time: Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward.
Measured: 1 day
Postoperative pain level
Postoperative pain level measured with the highest score in numeric pain rating scale (NRS).
Measured: 1 day
Postoperative opioid administration
Amount of postoperative opioid administration (piritramid) in the postanesthesia care unit (PACU). Piritramid is given if NRS score is > 3.
Measured: 1 day
Patient satisfaction
Patient satisfaction with the general anesthesia and pain management evaluated by a numeric rating scale.
Measured: 2-21 days
Release of stress hormones
Amount of perioperative plasma level of cortisol and ACTH.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start16 Oct 2017
- Primary completion5 Dec 2017
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to intervention groups by chance
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Nitzschke, MD, Principal investigator, Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical CenterSandra Funcke, MD, Principal investigator, Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303651
- Sponsor's protocol ID
- 20170824
- Acronym
- MOGADA
- Status last verified
- Apr 2018
- First submitted
- 28 Aug 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymized before publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Opioid Titration Guided by Analgesia Indices During General Anesthesia
- ClinicalTrials.gov ID
- NCT03303651
- Acronym / sponsor ID
- MOGADA / 20170824
- Conditions
- Pain, Pain, Postoperative, Nociceptive Pain, Opioid Use, Analgesia
- Keywords
- Analgesia, Monitoring, Opioid, Sufentanil, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- 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.
This prospective randomized clinical trial evaluates the effects of a monitor-guided opioid analgesia during general anesthesia. To date no standard-monitoring device exists to specifically reflect the analgesic component of general anesthesia. Quality and safety of general anesthesia are of major clinical importance and should be improved by limiting the opioid analgesic's dosage to the minimum amount needed. The study compares the effects of monitoring nociception during general anesthesia with different innovative techniques in comparison to routine clinical practice.
Detailed description
This prospective randomized clinical study aims to investigate the effects of a monitor-guided opioid analgesia during general anesthesia by different monitoring systems in comparison to routine clinical practice. Many surgical procedures require general anesthesia. The main components of general anesthesia are hypnosis and analgesia, and anesthesiologists usually combine a hypnotic drug with an opioid analgesic.
Until today, however, there is no standard-monitoring of nociception to specifically reflect the analgesic component of general anesthesia. In clinical practice the opioid dosage is chosen by clinical judgment of the attending anesthesiologist based upon changes of heart rate, blood pressure, pupil size, lacrimation and sweating of the patient.
On the one hand, underdosage of opioids can cause nociception leading to an increased sympathetic tone, increase of plasma levels of stress hormones, nociceptive movements as well as increase postoperative pain. On the other hand, overdosage of opioids can lead to drug side effects such as nausea and vomiting, hemodynamic instability, an increase in recovery times, immunosuppression and an increase in postoperative pain by opioid-induced-hyperalgesia. Quality and safety of general anesthesia are of major clinical importance and can be improved by limiting the administration of opioid analgesics to the optimal individual dose needed. In the last years, different analgesia monitoring devices have been developed for monitoring nociception. The present study evaluates the effects of the administration of opioids during general anesthesia guided by three different monitoring systems in comparison to routine clinical practice. After institutional approval by the Ethics committee of the Medical Board of the City of Hamburg, Germany and obtaining patients' written informed consent the investigators randomize elective patients with major abdominal surgery for open radical prostatectomy into one of four treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants are assigned to intervention groups by chance
| Arm | Type | Receives |
|---|---|---|
| PPI (Pain Pupillary Index) | Experimental | Procedure: Opioid administration in intervention groupsOpioid administration guided by Pain Pupillary Index (PPI) derived from Videopupillometry performed with the device AlgiScan manufactured by IDMed, Marseille, France. The device measures the degree of pupillary reflex dilation (PRD) following an electric nociceptive stimulation. It automatically increases the intensity of the electric stimulation from 10 to 60 milliampere depending on the degree of PRD and afterwards displays the PPI. The numerical index ranges from 0 to 10. A low PPI score indicates a deep analgesia, a high PPI score indicates an insufficient or light analgesia. A PPI score of 2 or 3 is supposed to represent an optimal level of analgesia according to the manufacturer. 5 µg sufentanil will be administered every 5 minutes if PPI score is calculated more than 3. |
| SPI (Surgical Pleth Index) | Experimental | Procedure: Opioid administration in intervention groupsOpioid administration (sufentanil) guided by by Surgical Pleth Index (SPI) derived from photoplethysmography performed by the device CARESCAPE B650 Patient Monitor from the manufacturer GE (General Electrics) Healthcare, Helsinki, Finland. Included in the monitoring system is a software that continuously calculates the SPI from normalized heart rate and pulse wave amplitude derived from finger plethysmography. The numerical index ranges between 0 (low sympathetic tone) and 100 (high sympathetic tone). A SPI score between 20 and 50 has been proposed as the target range to guide analgesics (15 - 17). 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50. |
| NOL (Nociception Level) | Experimental | Procedure: Opioid administration in intervention groupsOpioid administration (sufentanil) guided by Nociception Level (NOL) derived from finger photoplethysmography performed with the analgesia monitoring device PMD200 manufactured by Medasense, Ramat Gan, Israel. The device continuously calculates the NOL with a multi-parametric approach from pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, skin conductance fluctuations, skin temperature and finger motion. The composite algorithm of the device analyses the data and the numerical index NOL is presented on a scale from 0 (no pain) to 100 (extreme pain) (18). A NOL score between 10 and 25 has been proposed as the target range to guide analgesics. 5 µg Sufentanil will be administered every 5 minutes if NOL score is calculated more than 25. |
| Control | Active comparator | Procedure: Opioid administration in control groupOpioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation and sweating of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Radical open abdominal prostatectomy scheduled in the operation theater where the study is conducted
- > 18 years
Key exclusion criteria (6 listed)
- Chronic pain therapy, e.g. out-of-hospital opioid therapy
- Beta blocker and digitalis therapy
- Eye disease with affection of pupil reactivity
- Pacemaker therapy
- Higher degrees of cardiac arrhythmias, e.g. atrial fibrillation
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 |
|---|---|---|
| Opioid administration in intervention groupsElective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms. | Procedure or surgery | NOL (Nociception Level), PPI (Pain Pupillary Index), SPI (Surgical Pleth Index) |
| Opioid administration in control groupElective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group. | Procedure or surgery | Control |
Primary outcome
Intraoperative opioid consumption
Time frame: 1 day
Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.
6 secondary outcomes
Time to extubation
Time frame: 1 day
Time to fit-for-discharge
Time frame: 1 day
Postoperative pain level
Time frame: 1 day
Postoperative opioid administration
Time frame: 1 day
Patient satisfaction
Time frame: 2-21 days
Release of stress hormones
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Individual participant dataSharing planned: No. All data will be anonymized before publication.
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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.
Rainer Nitzschke, MD principal investigator
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Sandra Funcke, MD principal investigator
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid administration in intervention groups in people with Pain and Pain, Postoperative, run by Universitätsklinikum Hamburg-Eppendorf 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 6 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: finished, as of the sponsor's last update on 25 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative opioid consumption (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2018.