Monitor-Guided Analgesia During General Anesthesia - Part II
NCT ID: NCT03380949
Last Updated: 2019-04-30
Study Results
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Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2017-12-08
2018-06-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PPI (Pain Pupillary Index)
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.
Opioid administration (remifentanil) in intervention group
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by analgesia indices during general anesthesia in the experimental arms.
SPI (Surgical Pleth Index)
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.
Opioid administration (remifentanil) in intervention group
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by analgesia indices during general anesthesia in the experimental arms.
NOL (Nociception Level)
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.
Opioid administration (remifentanil) in intervention group
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by analgesia indices during general anesthesia in the experimental arms.
Control
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.
Opioid administration (remifentanil) in control group
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by clinical signs in the control group.
Interventions
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Opioid administration (remifentanil) in intervention group
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 group
Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by clinical signs in the control group.
Eligibility Criteria
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Inclusion Criteria
* \> 18 years
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Rainer Nitzschke, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Hamburg Eppendorf University Medical Center
Sandra Funcke, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Hamburg Eppendorf University Medical Center
Locations
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Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Hamburg, , Germany
Countries
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References
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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.
Other Identifiers
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20171120
Identifier Type: -
Identifier Source: org_study_id
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