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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03303651
Other study ID # 20170824
Secondary ID
Status Completed
Phase N/A
First received August 28, 2017
Last updated April 24, 2018
Start date October 16, 2017
Est. completion date January 26, 2018

Study information

Verified date April 2018
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 26, 2018
Est. primary completion date December 5, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Radical open abdominal prostatectomy scheduled in the operation theater where the study is conducted

- > 18 years

Exclusion Criteria:

- Chronic pain therapy, e.g. out-of-hospital 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

Study Design


Intervention

Procedure:
Opioid administration in intervention groups
Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms.
Opioid administration in control group
Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group.

Locations

Country Name City State
Germany Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative opioid consumption Compares the amount of intraoperative opioid administration (sufentanil) per minute of general anesthesia and per kg bodyweight between groups. 1 day
Secondary Time to extubation Postoperative recovery time: Time interval between end of operation and tracheal extubation of the patient. 1 day
Secondary 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. 1 day
Secondary Postoperative pain level Postoperative pain level measured with the highest score in numeric pain rating scale (NRS). 1 day
Secondary Postoperative opioid administration Amount of postoperative opioid administration (piritramid) in the postanesthesia care unit (PACU). Piritramid is given if NRS score is > 3. 1 day
Secondary Patient satisfaction Patient satisfaction with the general anesthesia and pain management evaluated by a numeric rating scale. 2-21 days
Secondary Release of stress hormones Amount of perioperative plasma level of cortisol and ACTH. 1 day
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