xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040307</url>
    </required_header>
    <id_info>
      <org_study_id>2023-08</org_study_id>
      <nct_id>NCT06040307</nct_id>
    </id_info>
    <brief_title>Guiding Opioid Administration in Patients With Regional Anesthesia</brief_title>
    <acronym>GORA</acronym>
    <official_title>Effect of Guiding Sufentanil Administration by Surgical Plethysmographic Index (SPI) Monitoring on Intraoperative Sufentanil Consumption in Patients Having Trauma and Orthopaedic Surgery With a Combination of General and Regional Anesthesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitätsklinikum Hamburg-Eppendorf</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid&#xD;
        analgesics to ensure antinociception. An alternative approach to the intraoperative&#xD;
        administration of high potency opioids in order to achieve antinociception during surgery is&#xD;
        combining a general anesthesia with a regional anesthesia.&#xD;
  &#xD;
        Modern general anesthesia aims to treat nociception induced by surgical stimulation while&#xD;
        avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration.&#xD;
        Quality and safety of general anesthesia are of major clinical importance and can be improved&#xD;
        by adjusting the opioid analgesics to the optimal individual dose needed.&#xD;
  &#xD;
        In the current clinical practice, the opioid dosage is usually chosen by clinical judgment.&#xD;
        Recently different monitoring devices estimating the effect of nociception during&#xD;
        unconsciousness have become commercially available. One of the first commercially available&#xD;
        nociception indices was the Surgical Pleth Index (SPI) derived by the CARESCAPE™B650 patient&#xD;
        monitor (GE Healthcare).&#xD;
  &#xD;
        Until today, it remains unknown whether guiding sufentanil administration by SPI monitoring&#xD;
        affects the administered amount of intraoperative and postoperative opioid, immediate&#xD;
        postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative&#xD;
        recovery in patients with a combination of general and regional anesthesia. This study aims&#xD;
        to investigate whether guiding sufentanil administration by SPI monitoring - compared to&#xD;
        routine care - reduces intraoperative sufentanil consumption in patients having trauma and&#xD;
        orthopaedic surgery with a combination of general and regional anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        General anesthesia is a combination of hypnotic drugs and opioid analgesics. Modern general&#xD;
        anesthesia aims to treat nociception induced by surgical stimulation while avoiding an&#xD;
        overdose of opioid analgesics and reducing side-effects of opioid administration. Underdosing&#xD;
        of opioids during surgery can lead to nociception with increased sympathetic tone, elevated&#xD;
        levels of stress hormones, unintended patient movement due to nociception as well as&#xD;
        increased postoperative pain. On the other hand, overdosing of opioids can lead to negative&#xD;
        side effects such as nausea and vomiting, arterial hypotension, immunosuppression, prolonged&#xD;
        recovery times, postoperative delirium and an increase in postoperative pain by&#xD;
        opioid-induced-hyperalgesia. Anesthesiologists aim for a long-lasting perioperative&#xD;
        anesthesia while at the same time trying to reduce the intraoperative and postoperative&#xD;
        opioid administration.&#xD;
  &#xD;
        An alternative approach to the intraoperative administration of high potency opioids in order&#xD;
        to achieve antinociception during surgery is combining a general anesthesia with a regional&#xD;
        anesthesia. However, the quality of regional anesthesia cannot be assessed during general&#xD;
        anesthesia by the anesthesiologist and patients cannot express pain themselves. Therefore,&#xD;
        anesthesiologists tend to administer a certain calculated opioid dose during the operation.&#xD;
        If this calculated opioid administration is essential for a sufficient anesthesia or an&#xD;
        unnecessary overdose cannot be assessed by the anesthesiologist. Until now there has been no&#xD;
        measurement tool that could estimate the effectiveness of regional anesthesia and the absence&#xD;
        of nociception during general anesthesia combined with a regional anesthesia.&#xD;
  &#xD;
        In recent years, different monitoring devices estimating the effect of nociception during&#xD;
        unconsciousness have become commercially available. Such monitoring devices should help&#xD;
        physicians to choose the right dose of opioid analgesics during general anesthesia. Among&#xD;
        those, the Surgical Pleth Index (SPI) was one of the first commercially available nociception&#xD;
        monitoring devices. The SPI is derived by the CARESCAPE™B650 patient monitor (GE Healthcare)&#xD;
        and calculates an index value from normalized heart rate and pulse wave amplitude derived by&#xD;
        photoplethysmography. The index is presented on a scale from 0 (low sympathetic tone) to 100&#xD;
        (high sympathetic tone). Nevertheless, current literature is inconclusive about the impact of&#xD;
        nociception-monitor-guided opioid administration. So far, there is no definitive evidence on&#xD;
        anesthesia related outcome parameters like the administered amount of opioid, postoperative&#xD;
        short-term recovery, and long-term outcome. Besides, there has been no study evaluating the&#xD;
        assessment of the effectiveness of regional anesthesia during general anesthesia by&#xD;
        monitoring the intraoperative nociception with the SPI. If the SPI was able to assess&#xD;
        nociception, SPI guided opioid administration would prevent unnecessary opioid administration&#xD;
        during the operation and reduce the total dose of opioids. Reduction of the intraoperative&#xD;
        opioid dose would mean a clinically important benefit for patients against the background of&#xD;
        potential risks of opioid administration. Nevertheless, it remains unknown whether guiding&#xD;
        sufentanil administration by SPI monitoring effects the administered amount of intraoperative&#xD;
        and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU)&#xD;
        and the quality of postoperative recovery in patients with a combination of general and&#xD;
        regional anesthesia.&#xD;
  &#xD;
        This prospective, randomized controlled trial aims to investigate whether guiding sufentanil&#xD;
        administration by SPI monitoring - compared to routine care - reduces intraoperative&#xD;
        sufentanil consumption in patients having trauma and orthopaedic surgery with a combination&#xD;
        of general and regional anesthesia. The hypothesis tested in the present study is that in&#xD;
        patients having trauma and orthopaedic surgery with a combination of general and regional&#xD;
        anesthesia guiding sufentanil administration of sufentanil guided by SPI monitoring reduces&#xD;
        intraoperative sufentanil consumption compared to routine care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants are assigned to intervention groups by chance</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Single-blinded to the primary endpoint (intraoperative amount of sufentanil). Participants are not informed about the group assignment (intervention takes place in general anesthesia). The attending anesthesiologists can not be blinded to the group-allocation, because the study involves intervention during the intraoperative treatment. The study is double-blinded regarding the secondary endpoints. Postoperative outcome parameters are assessed by members of the study team. These outcome-assessors are blinded to the group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Intraoperative Sufentanil Consumption</measure>
      <time_frame>1 day</time_frame>
      <description>Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Highest postoperative pain level at the PACU</measure>
      <time_frame>1 day</time_frame>
      <description>Postoperative pain level measured with the highest score in numeric pain rating scale (NRS 0-10) at the postanesthesia care unit (PACU)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median postoperative pain level at the PACU</measure>
      <time_frame>1 day</time_frame>
      <description>Postoperative pain level measured with the median score in numeric pain rating scale (NRS 0-10) at the postanesthesia care unit (PACU)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of moderate to severe postoperative pain</measure>
      <time_frame>1 day</time_frame>
      <description>Incidence of moderate to severe postoperative pain (NRS 4-10) at the postanesthesia care unit (PACU)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative opioids</measure>
      <time_frame>1 day</time_frame>
      <description>Postoperative administered amount of opioids in morphine equivalents (mg) at the postanesthesia care unit (PACU)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PONV</measure>
      <time_frame>1 day</time_frame>
      <description>Incidence of postoperative nausea and vomiting (PONV) at the postanesthesia care unit (PACU)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PACU stay</measure>
      <time_frame>1 day</time_frame>
      <description>Length of stay at the postanesthesia care unit (PACU) (min) until patients reach fit-for-discharge status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after 24 hours</measure>
      <time_frame>2 days</time_frame>
      <description>Pain level at rest (NRS 0-10) 24 hours after the operation on the ward</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality-of-Recovery (QoR-15)</measure>
      <time_frame>2 days</time_frame>
      <description>Quality of postoperative recovery measured by the Quality-of-Recovery QoR-15 (0-120 points) 24 hours after the operation on the ward</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Nociceptive Pain</condition>
    <condition>Pain, Postoperative</condition>
    <condition>Analgesia</condition>
    <condition>Anesthesia Recovery Period</condition>
    <condition>Opioid Use</condition>
    <arm_group>
      <arm_group_label>SPI (Surgical Pleth Index)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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 Electric) Healthcare, Boston, Massachusetts, US. Included in the monitoring system is a software that continuously calculates the SPI from normalized heart rate and pulse wave amplitude derived from finger photoplethysmography. 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 opioid analgesics. 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation, sweating and spontaneous movements of the patient. As an orientation anesthesiologists are advised to administer 5 µg sufentanil if systolic blood pressure is &gt; 140 mmHg or mean blood pressure is &gt; 100 mmHg or heart rate is &gt; 90 /min. If assessed necessary, the anaesthesiologists are allowed to administer higher or lower sufentanil doses up to their discretion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>SPI (Surgical Pleth Index)</intervention_name>
      <description>Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by SPI during general anesthesia in the experimental arm.</description>
      <arm_group_label>SPI (Surgical Pleth Index)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients having elective trauma or orthopaedic surgery with a combination of general&#xD;
               and regional anaesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preexisting therapy with beta-blockers, cardiac glycosides or pacemakers&#xD;
  &#xD;
            -  Cardiac arrhythmia (atrial fibrillation, atrioventricular block &gt; I°)&#xD;
  &#xD;
            -  Intraoperative treatment with ketamine, beta blockers, beta-adrenergic agonists or&#xD;
               clonidine&#xD;
  &#xD;
            -  Serious peripheral or cardiac autonomic neuropathy&#xD;
  &#xD;
            -  Inability to specify the postoperative pain level&#xD;
  &#xD;
            -  Postoperative treatment in an Intensive Care Unit&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rainer Nitzschke, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rainer Nitzschke, MD</last_name>
      <phone>+4915222815884</phone>
      <email>r.nitzschke@uke.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Annika Zoller</last_name>
      <phone>+49040741052415</phone>
      <email>ana-sek@uke.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center</name>
        <address>
          <city>Hamburg</city>
          <zip>20246</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>General Anesthesia</keyword>
    <keyword>Regional Anesthesia</keyword>
    <keyword>Analgesia Monitoring</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Nociceptive Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040307
  org study id: 2023-08
  nct id: NCT06040307
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  General anesthesia is a combination of hypnotic drugs to achieve unconsciousness and opioid
        analgesics to ensure antinociception. An alternative approach to the intraoperative
        administration of high potency opioids in order to achieve antinociception during surgery is
        combining a general anesthesia with a regional anesthesia.
  
        Modern general anesthesia aims to treat nociception induced by surgical stimulation while
        avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration.
        Quality and safety of general anesthesia are of major clinical importance and can be improved
        by adjusting the opioid analgesics to the optimal individual dose needed.
  
        In the current clinical practice, the opioid dosage is usually chosen by clinical judgment.
        Recently different monitoring devices estimating the effect of nociception during
        unconsciousness have become commercially available. One of the first commercially available
        nociception indices was the Surgical Pleth Index (SPI) derived by the CARESCAPE™B650 patient
        monitor (GE Healthcare).
  
        Until today, it remains unknown whether guiding sufentanil administration by SPI monitoring
        affects the administered amount of intraoperative and postoperative opioid, immediate
        postoperative pain in the postanesthesia care unit (PACU) and the quality of postoperative
        recovery in patients with a combination of general and regional anesthesia. This study aims
        to investigate whether guiding sufentanil administration by SPI monitoring - compared to
        routine care - reduces intraoperative sufentanil consumption in patients having trauma and
        orthopaedic surgery with a combination of general and regional anesthesia.
  General anesthesia is a combination of hypnotic drugs and opioid analgesics. Modern general
        anesthesia aims to treat nociception induced by surgical stimulation while avoiding an
        overdose of opioid analgesics and reducing side-effects of opioid administration. Underdosing
        of opioids during surgery can lead to nociception with increased sympathetic tone, elevated
        levels of stress hormones, unintended patient movement due to nociception as well as
        increased postoperative pain. On the other hand, overdosing of opioids can lead to negative
        side effects such as nausea and vomiting, arterial hypotension, immunosuppression, prolonged
        recovery times, postoperative delirium and an increase in postoperative pain by
        opioid-induced-hyperalgesia. Anesthesiologists aim for a long-lasting perioperative
        anesthesia while at the same time trying to reduce the intraoperative and postoperative
        opioid administration.
  
        An alternative approach to the intraoperative administration of high potency opioids in order
        to achieve antinociception during surgery is combining a general anesthesia with a regional
        anesthesia. However, the quality of regional anesthesia cannot be assessed during general
        anesthesia by the anesthesiologist and patients cannot express pain themselves. Therefore,
        anesthesiologists tend to administer a certain calculated opioid dose during the operation.
        If this calculated opioid administration is essential for a sufficient anesthesia or an
        unnecessary overdose cannot be assessed by the anesthesiologist. Until now there has been no
        measurement tool that could estimate the effectiveness of regional anesthesia and the absence
        of nociception during general anesthesia combined with a regional anesthesia.
  
        In recent years, different monitoring devices estimating the effect of nociception during
        unconsciousness have become commercially available. Such monitoring devices should help
        physicians to choose the right dose of opioid analgesics during general anesthesia. Among
        those, the Surgical Pleth Index (SPI) was one of the first commercially available nociception
        monitoring devices. The SPI is derived by the CARESCAPE™B650 patient monitor (GE Healthcare)
        and calculates an index value from normalized heart rate and pulse wave amplitude derived by
        photoplethysmography. The index is presented on a scale from 0 (low sympathetic tone) to 100
        (high sympathetic tone). Nevertheless, current literature is inconclusive about the impact of
        nociception-monitor-guided opioid administration. So far, there is no definitive evidence on
        anesthesia related outcome parameters like the administered amount of opioid, postoperative
        short-term recovery, and long-term outcome. Besides, there has been no study evaluating the
        assessment of the effectiveness of regional anesthesia during general anesthesia by
        monitoring the intraoperative nociception with the SPI. If the SPI was able to assess
        nociception, SPI guided opioid administration would prevent unnecessary opioid administration
        during the operation and reduce the total dose of opioids. Reduction of the intraoperative
        opioid dose would mean a clinically important benefit for patients against the background of
        potential risks of opioid administration. Nevertheless, it remains unknown whether guiding
        sufentanil administration by SPI monitoring effects the administered amount of intraoperative
        and postoperative opioid, immediate postoperative pain in the postanesthesia care unit (PACU)
        and the quality of postoperative recovery in patients with a combination of general and
        regional anesthesia.
  
        This prospective, randomized controlled trial aims to investigate whether guiding sufentanil
        administration by SPI monitoring - compared to routine care - reduces intraoperative
        sufentanil consumption in patients having trauma and orthopaedic surgery with a combination
        of general and regional anesthesia. The hypothesis tested in the present study is that in
        patients having trauma and orthopaedic surgery with a combination of general and regional
        anesthesia guiding sufentanil administration of sufentanil guided by SPI monitoring reduces
        intraoperative sufentanil consumption compared to routine care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants are assigned to intervention groups by chance
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Single-blinded to the primary endpoint (intraoperative amount of sufentanil). Participants are not informed about the group assignment (intervention takes place in general anesthesia). The attending anesthesiologists can not be blinded to the group-allocation, because the study involves intervention during the intraoperative treatment. The study is double-blinded regarding the secondary endpoints. Postoperative outcome parameters are assessed by members of the study team. These outcome-assessors are blinded to the group assignment.
  measure: Intraoperative Sufentanil Consumption
  time frame: 1 day
  description: Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups.
  measure: Highest postoperative pain level at the PACU
  time frame: 1 day
  description: Postoperative pain level measured with the highest score in numeric pain rating scale (NRS 0-10) at the postanesthesia care unit (PACU)
  measure: Median postoperative pain level at the PACU
  time frame: 1 day
  description: Postoperative pain level measured with the median score in numeric pain rating scale (NRS 0-10) at the postanesthesia care unit (PACU)
  measure: Incidence of moderate to severe postoperative pain
  time frame: 1 day
  description: Incidence of moderate to severe postoperative pain (NRS 4-10) at the postanesthesia care unit (PACU)
  measure: Postoperative opioids
  time frame: 1 day
  description: Postoperative administered amount of opioids in morphine equivalents (mg) at the postanesthesia care unit (PACU)
  measure: PONV
  time frame: 1 day
  description: Incidence of postoperative nausea and vomiting (PONV) at the postanesthesia care unit (PACU)
  measure: PACU stay
  time frame: 1 day
  description: Length of stay at the postanesthesia care unit (PACU) (min) until patients reach fit-for-discharge status
  measure: Pain after 24 hours
  time frame: 2 days
  description: Pain level at rest (NRS 0-10) 24 hours after the operation on the ward
  measure: Quality-of-Recovery (QoR-15)
  time frame: 2 days
  description: Quality of postoperative recovery measured by the Quality-of-Recovery QoR-15 (0-120 points) 24 hours after the operation on the ward
  arm group label: SPI (Surgical Pleth Index)
  arm group type: Experimental
  description: 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 Electric) Healthcare, Boston, Massachusetts, US. Included in the monitoring system is a software that continuously calculates the SPI from normalized heart rate and pulse wave amplitude derived from finger photoplethysmography. 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 opioid analgesics. 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50.
  arm group label: Control
  arm group type: No Intervention
  description: Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation, sweating and spontaneous movements of the patient. As an orientation anesthesiologists are advised to administer 5 µg sufentanil if systolic blood pressure is > 140 mmHg or mean blood pressure is > 100 mmHg or heart rate is > 90 /min. If assessed necessary, the anaesthesiologists are allowed to administer higher or lower sufentanil doses up to their discretion.
  intervention type: Procedure
  intervention name: SPI (Surgical Pleth Index)
  description: Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by SPI during general anesthesia in the experimental arm.
  arm group label: SPI (Surgical Pleth Index)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rainer Nitzschke, MD
  role: Principal Investigator
  affiliation: Universitätsklinikum Hamburg-Eppendorf
  last name: Rainer Nitzschke, MD
  phone: +4915222815884
  email: r.nitzschke@uke.de
  last name: Annika Zoller
  phone: +49040741052415
  email: ana-sek@uke.de
  facility: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Nociceptive Pain