Clinical trial NCT03380949: Monitor-Guided Analgesia During General Anesthesia - Part II
Official title: Investigation of the Effect of Opioid Titration Guided by Analgesia Indices During Total Intravenous Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pain
Nociceptive Pain
Opioid Use
Analgesia
Keywords: Analgesia
Monitoring
Opioid
Sufentanil
Sevoflurane
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to intervention groups by chance
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Radical open abdominal prostatectomy scheduled in the operation theater where the study is conducted
* \> 18 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intraoperative opioid consumption
timeFrame: 1 day
Secondary outcomes:
measure: Time to extubation
timeFrame: 1 day
measure: Time to Fit-for-discharge
timeFrame: 1 day
measure: Postoperative pain level
timeFrame: 1 day
measure: Postoperative opioid administration
timeFrame: 1 day
measure: Patient satisfaction
timeFrame: 2-21 days
measure: Release of stress hormones
timeFrame: 1 day
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Study officials:
affiliation: Department of Anesthesiology, Hamburg Eppendorf University Medical Center
name: Rainer Nitzschke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Hamburg Eppendorf University Medical Center
name: Sandra Funcke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.