Monitor-Guided Analgesia During General Anesthesia - Part I

NCT03303651 | Completed

• 1 other identifier: 20170824
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Pain, Postoperative; Nociceptive Pain; Opioid Use; Analgesia

Keywords

Analgesia, Monitoring, Opioid, Sufentanil, Sevoflurane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to extubation

  1 day

• Time to fit-for-discharge

  1 day

• Postoperative pain level

  1 day

• Postoperative opioid administration

  1 day

• Patient satisfaction

  2-21 days

Study Arms (4)

PPI (Pain Pupillary Index)

EXPERIMENTAL

Opioid administration guided by Pain Pupillary Index (PPI) derived from Videopupillometry performed with the device AlgiScan manufactured by IDMed, Marseille, France. The device measures the degree of pupillary reflex dilation (PRD) following an electric nociceptive stimulation. It automatically increases the intensity of the electric stimulation from 10 to 60 milliampere depending on the degree of PRD and afterwards displays the PPI. The numerical index ranges from 0 to 10. A low PPI score indicates a deep analgesia, a high PPI score indicates an insufficient or light analgesia. A PPI score of 2 or 3 is supposed to represent an optimal level of analgesia according to the manufacturer. 5 µg sufentanil will be administered every 5 minutes if PPI score is calculated more than 3.

Procedure: Opioid administration in intervention groups

SPI (Surgical Pleth Index)

EXPERIMENTAL

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 Electrics) 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 to guide analgesics (15 - 17). 5 µg Sufentanil will be administered every 5 minutes if SPI score is calculated more than 50.

Procedure: Opioid administration in intervention groups

NOL (Nociception Level)

EXPERIMENTAL

Opioid administration (sufentanil) guided by Nociception Level (NOL) derived from finger photoplethysmography performed with the analgesia monitoring 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, skin conductance fluctuations, skin temperature and finger motion. The composite algorithm of the device analyses the data and the numerical index NOL is presented on a scale from 0 (no pain) to 100 (extreme pain) (18). A NOL score between 10 and 25 has been proposed as the target range to guide analgesics. 5 µg Sufentanil will be administered every 5 minutes if NOL score is calculated more than 25.

Procedure: Opioid administration in intervention groups

Control

ACTIVE COMPARATOR

Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist based upon changes of heart rate, blood pressure, lacrimation and sweating of the patient.

Procedure: Opioid administration in control group

Interventions

Opioid administration in intervention groups PROCEDURE

Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms.

NOL (Nociception Level); PPI (Pain Pupillary Index); SPI (Surgical Pleth Index)

Opioid administration in control group PROCEDURE

Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

Hamburg, 20257, Germany

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative; Nociceptive Pain; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rainer Nitzschke, MD

  Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

  PRINCIPAL INVESTIGATOR

• Sandra Funcke, MD

  Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are not informed about the group assignement (intervention takes place in general anesthesia). Outcome assessors are persons without knowledge on former treatment in intervention/control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to intervention groups by chance

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: October 6, 2017
• Study Start: October 16, 2017
• Primary Completion: December 5, 2017
• Study Completion: January 26, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)