An interventional study of Opioid administration in intervention groups and Opioid administration in control group in Pain, Pain, Postoperative and Nociceptive Pain, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-25.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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Among 201 studies in Pain with a site in Germany — 13 open to participants now, 14 under way, 8 of them phase 3. Pain · Germany.
Among the 201 studies in Pain with a site in Germany, this one is the 135th largest by enrollment of the 162 interventional ones that give a count, is one of 7 that started in 2017, is one of 58 with no phase, and was the 143rd registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →13 of the 201 studies in Pain with a site in Germany are open now. Recruiting first, the newest first:
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · Sites in Germany
Ages 18–99 · Women only
Apurano Pharmaceuticals GmbH · Sites in Germany
Ages 18+
Apurano Pharmaceuticals GmbH · Sites in Germany
Ages 18+
Apurano Pharmaceuticals GmbH · Sites in Germany
Ages 18+
Apurano Pharmaceuticals GmbH · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
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201 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 33 · Phase 3 50 · Phase 4 13
First in 2001; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 48 is below the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 111 across the 162 interventional studies, 100 across the 39 observational. Of the 169 that completed or were terminated, 49 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
95 of 201 have an industry lead sponsor. The 10 most frequent:
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Universitätsklinikum Hamburg-Eppendorf has 3 studies filed under Pain — fewer than ten, so there is no comparison to draw.
2 of the studies in Pain with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07423039Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery (ROSA) | 2027-06-30 |
| NCT05867186Johannes Gutenberg University MainzFit to Fight Childhood Cancer | 2027-07-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 201 studies in Pain with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Opioid administration in intervention groups
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.
Procedure: Opioid administration in intervention groups
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.
Procedure: Opioid administration in intervention groups
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.
Procedure: Opioid administration in control group
Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms.
Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group.
Intraoperative opioid consumption
Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.
Time frame: 1 day
Time to extubation
Postoperative recovery time: Time interval between end of operation and tracheal extubation of the patient.
Time frame: 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.
Time frame: 1 day
Postoperative pain level
Postoperative pain level measured with the highest score in numeric pain rating scale (NRS).
Time frame: 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.
Time frame: 1 day
Patient satisfaction
Patient satisfaction with the general anesthesia and pain management evaluated by a numeric rating scale.
Time frame: 2-21 days
Release of stress hormones
Amount of perioperative plasma level of cortisol and ACTH.
Time frame: 1 day
Plan to share: No — All data will be anonymized before publication.
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Dec 2017, 1 month.
Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 1 month is below that.
Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf →