Monitor-Guided Analgesia During General Anesthesia - Part II

Pain Clinical Trial

— MOGADA-II  

Official title:

Investigation of the Effect of Opioid Titration Guided by Analgesia Indices During Total Intravenous Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380949
• Other study ID #: 20171120
• Status: Completed
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: June 7, 2018

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 7, 2018
• Est. primary completion date: April 18, 2018
• 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 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

Related Conditions & MeSH terms

• Analgesia
• Nociceptive Pain
• Opioid Use
• Pain
• Pain, Postoperative

Intervention

Procedure:
• 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.

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 (remifentanil) 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.; 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