An interventional study of Opioid administration (remifentanil) in intervention group and Opioid administration (remifentanil) in control group in Pain, Postoperative, Pain 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 2019-04-30.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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Among 50 studies in Pain, Postoperative with a site in Germany — 11 open to participants now, 11 under way, 2 of them phase 3. Pain, Postoperative · Germany.
Among the 50 studies in Pain, Postoperative with a site in Germany, this one is the 24th largest by enrollment of the 40 interventional ones that give a count, is one of 4 that started in 2017, is one of 21 with no phase, and was the 31st registered.
5,644 studies on the registry are indexed under Pain, Postoperative; 1,229 are open to participants now.
Browse Pain, Postoperative studies →11 of the 50 studies in Pain, Postoperative with a site in Germany are open now. Recruiting first, the newest first:
Prof. Dr. med. Andreas Halder · Sites in Germany
Ages 18+
Hannover Medical School · Sites in Germany
Ages 18+
Goethe University · Sites in Germany
Ages 18+
Aesculap AG · Sites in Germany
Ages 18+
Universitätsklinikum Hamburg-Eppendorf · 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 678 Pain, Postoperative studies recruiting now, 241 (36%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
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50 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 2 8 · Phase 3 7 · Phase 4 7
First in 2003; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 96 is above the median of 75 across 4,825 interventional studies indexed under Pain, Postoperative.
Median enrollment 106 across the 40 interventional studies, 2,161 across the 10 observational. Of the 37 that completed or were terminated, 6 (16%) have results posted.
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13 of 50 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 6 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
3 of the studies in Pain, Postoperative 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 |
|---|---|
| NCT07568093Hannover Medical SchoolPARO-agitation-study | 2026-12 |
| NCT07008261Goethe UniversityRobot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions. | 2027-05-30 |
| NCT06960018Aesculap AGClinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement | 2027-11 |
Add all 3 to your calendar (.ics) → With an account.
Among the 50 studies in Pain, Postoperative 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. 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.
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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 (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.
Procedure: Opioid administration (remifentanil) in intervention group
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.
Procedure: Opioid administration (remifentanil) in intervention group
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.
Procedure: Opioid administration (remifentanil) in intervention group
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.
Procedure: Opioid administration (remifentanil) in control group
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by analgesia indices during general anesthesia in the experimental arms.
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by clinical signs in the control group.
Intraoperative opioid consumption
Compares the amount of intraoperative opioid administration (remifentanil) 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. 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.
Ran from Dec 2017 to primary completion in Apr 2018, 4 months.
Of 2,094 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 4 months is below that.
Counting every sponsor, half of 2,107 studies reached it within 11 months; a quarter within 6 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 2019. You cannot join it, but the record below documents what was studied.
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