Monitor-Guided Analgesia During General Anesthesia - Part II

NCT03380949 | Completed

• 1 other identifier: 20171120
• Study Type: interventional
• Target: 96
• 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, Postoperative; Pain; 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 (remifentanil) 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 (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.

Procedure: Opioid administration (remifentanil) in intervention group

SPI (Surgical Pleth Index)

EXPERIMENTAL

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.

Procedure: Opioid administration (remifentanil) in intervention group

NOL (Nociception Level)

EXPERIMENTAL

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.

Procedure: Opioid administration (remifentanil) in intervention group

Control

ACTIVE COMPARATOR

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.

Procedure: Opioid administration (remifentanil) in control group

Interventions

Opioid administration (remifentanil) in intervention group PROCEDURE

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); PPI (Pain Pupillary Index); SPI (Surgical Pleth Index)

Opioid administration (remifentanil) in control group PROCEDURE

Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) 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 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, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 33228979 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Nociceptive Pain; Agnosia

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rainer Nitzschke, MD

  Department of Anesthesiology, Hamburg Eppendorf University Medical Center

  PRINCIPAL INVESTIGATOR

• Sandra Funcke, MD

  Department of Anesthesiology, 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: November 29, 2017
• First Posted: December 21, 2017
• Study Start: December 8, 2017
• Primary Completion: April 18, 2018
• Study Completion: June 7, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)