Pain, PostoperativeMOGADA-IINCT03380949
Monitor-Guided Analgesia During General Anesthesia - Part II
A study testing Opioid administration (remifentanil) in intervention group in people with Pain, Postoperative and Pain, 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, Postoperative, Pain, Nociceptive Pain
- What is being tested?
- Opioid administration (remifentanil) in intervention group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2017to 7 Jun 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 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, 20246
About this study
Official title: Investigation of the Effect of Opioid Titration Guided by Analgesia Indices During Total Intravenous 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. All patients will receive general anesthesia with propofol guided by bispectral index (BIS) with a target of BIS values between 40 and 60. Opioid administration will be guided by one of three analgesic monitoring devices or the interpretation of clinical signs by the attending anesthesiologist in the control group. After institutional approval by the Ethics committee of the Medical Board of the City of Hamburg, Germany and obtaining patients' written informed consent we randomize elective patients with major abdominal surgery for open radical prostatectomy into one of four treatment groups.
- Conditions
- Pain, Postoperative, Pain, Nociceptive Pain, Opioid Use, Analgesia
- Being tested
- Opioid administration (remifentanil) in intervention group, Opioid administration (remifentanil) in control group
- Keywords
- Analgesia, Monitoring, Opioid, Sufentanil, Sevoflurane
- Medical subject headings
- Pain, Postoperative, Pain, Nociceptive Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid administration (remifentanil) in intervention groupProcedure or surgery
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by analgesia indices during general anesthesia in the experimental arms.
Opioid administration (remifentanil) in control groupProcedure or surgery
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by clinical signs in the control group.
| Study group | Role | What they receive |
|---|---|---|
| PPI (Pain Pupillary Index) | Experimental | Opioid administration (remifentanil) in intervention group is guided by PPI derived from video-pupillometry performed with the AlgiScan™ by IDMed, Marseille, France. The device measures the degree of pupillary reflex dilation (PRD) following a nociceptive stimulation. It automatically increases the intensity of the electric stimulation from 10 to 60 mA and displays the PPI as numerical index between 0 and 10. A low PPI score indicates deep, a high score light analgesia. A PPI score of 2-3 is supposed to represent an optimal level of analgesia. A remifentanil bolus of 30 µg will be administered and the infusion rate of remifentanil will be increased by 0.03 µg/kg/min if PPI score is calculated more than 3. Remifentanil infusion will be decreased by 0.03 µg/kg/min if PPI score is <1. Receives: Procedure: Opioid administration (remifentanil) in intervention group |
| SPI (Surgical Pleth Index) | Experimental | Opioid administration (remifentanil) in intervention group is guided by SPI derived from photoplethysmography performed by the device CARESCAPE™ B650 Patient Monitor by GE 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. A remifentanil bolus of 30 µg will be administered and the infusion rate of remifentanil will be increased by 0.03 µg/kg/min if SPI score is calculated more than 50. Remifentanil infusion will be decreased by 0.03 µg/kg/min if PPI score is calculated below 20. Receives: Procedure: Opioid administration (remifentanil) in intervention group |
| NOL (Nociception Level) | Experimental | Opioid administration (remifentanil) in intervention group is guided by NOL derived from finger photoplethysmography performed with the 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 and fluctuations, skin temperature and finger motion. It is presented on a scale from 0 (no pain) to 100 (extreme pain). A NOL score between 10 and 25 has been proposed as the target range. A remifentanil bolus of 30 µg will be administered and the infusion rate will be increased by 0.03 µg/kg/min if NOL score is calculated more than 25. Remifentanil infusion will be decreased by 0.03 µg/kg/min if PPI score is calculated below 10. Receives: Procedure: Opioid administration (remifentanil) in intervention group |
| Control | Active comparator | Opioid administration (remifentanil) in control group is 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 (remifentanil) 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 (remifentanil) 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.
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 posted21 Dec 2017
- Study start8 Dec 2017
- Primary completion18 Apr 2018
- Study completion7 Jun 2018
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 Pain, PostoperativeStudies 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
- 96 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, Hamburg Eppendorf University Medical CenterSandra Funcke, MD, Principal investigator, Department of Anesthesiology, Hamburg Eppendorf University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380949
- Sponsor's protocol ID
- 20171120
- Acronym
- MOGADA-II
- Status last verified
- Apr 2019
- First submitted
- 29 Nov 2017
- Last updated
- 30 Apr 2019
- 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.
Publications
Funcke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20.
PubMed 33228979
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. 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 Total Intravenous Anesthesia
- ClinicalTrials.gov ID
- NCT03380949
- Acronym / sponsor ID
- MOGADA-II / 20171120
- Conditions
- Pain, Postoperative, Pain, Nociceptive Pain, Opioid Use, Analgesia
- Keywords
- Analgesia, Monitoring, Opioid, Sufentanil, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 21 Dec 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. All patients will receive general anesthesia with propofol guided by bispectral index (BIS) with a target of BIS values between 40 and 60. Opioid administration will be guided by one of three analgesic monitoring devices or the interpretation of clinical signs by the attending anesthesiologist in the control group. After institutional approval by the Ethics committee of the Medical Board of the City of Hamburg, Germany and obtaining patients' written informed consent we 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 (remifentanil) in intervention groupOpioid administration (remifentanil) in intervention group is guided by PPI derived from video-pupillometry performed with the AlgiScan™ by IDMed, Marseille, France. The device measures the degree of pupillary reflex dilation (PRD) following a nociceptive stimulation. It automatically increases the intensity of the electric stimulation from 10 to 60 mA and displays the PPI as numerical index between 0 and 10. A low PPI score indicates deep, a high score light analgesia. A PPI score of 2-3 is supposed to represent an optimal level of analgesia. A remifentanil bolus of 30 µg will be administered and the infusion rate of remifentanil will be increased by 0.03 µg/kg/min if PPI score is calculated more than 3. Remifentanil infusion will be decreased by 0.03 µg/kg/min if PPI score is <1. |
| SPI (Surgical Pleth Index) | Experimental | Procedure: Opioid administration (remifentanil) in intervention groupOpioid administration (remifentanil) in intervention group is guided by SPI derived from photoplethysmography performed by the device CARESCAPE™ B650 Patient Monitor by GE 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. A remifentanil bolus of 30 µg will be administered and the infusion rate of remifentanil will be increased by 0.03 µg/kg/min if SPI score is calculated more than 50. Remifentanil infusion will be decreased by 0.03 µg/kg/min if PPI score is calculated below 20. |
| NOL (Nociception Level) | Experimental | Procedure: Opioid administration (remifentanil) in intervention groupOpioid administration (remifentanil) in intervention group is guided by NOL derived from finger photoplethysmography performed with the 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 and fluctuations, skin temperature and finger motion. It is presented on a scale from 0 (no pain) to 100 (extreme pain). A NOL score between 10 and 25 has been proposed as the target range. A remifentanil bolus of 30 µg will be administered and the infusion rate will be increased by 0.03 µg/kg/min if NOL score is calculated more than 25. Remifentanil infusion will be decreased by 0.03 µg/kg/min if PPI score is calculated below 10. |
| Control | Active comparator | Procedure: Opioid administration (remifentanil) in control groupOpioid administration (remifentanil) in control group is 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 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 (remifentanil) in intervention groupElective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) 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 (remifentanil) in control groupElective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) 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 (remifentanil) 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 30 Apr 2019.
- Derived from this study: PubMed 33228979Funcke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20.
- Individual participant dataSharing planned: No. All data will be anonymized before publication.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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, Hamburg Eppendorf University Medical Center
Sandra Funcke, MD principal investigator
Department of Anesthesiology, 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 (remifentanil) in intervention group in people with Pain, Postoperative and Pain, 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 30 Apr 2019. 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?
On the ClinicalTrials.gov record for NCT03380949, 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 30 Apr 2019.