The Medasense Study

April 2, 2015 updated by: Albert Dahan, Leiden University Medical Center

Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index

Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-80 years;
  • Sex: male or female;
  • Surgery: Any surgery under general anesthesia;
  • ASA status: 1, 2 or 3.

Exclusion Criteria:

  • Age: < 18 or > 80 years;
  • Unable to give written informed consent;
  • Pregnancy/lactation;
  • Extreme obesity: BMI > 35;
  • Perceived difficult intubation.
  • Patients requiring a rapid sequence induction
  • Patients on beta-blockers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PROPOFOL ONLY GROUP
In this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5-min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5-min the laryngoscope will be placed again and the patient will be intubated. This will be done without additional administration of muscle relaxant.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Experimental: PROPOFOL + REMIFENTANIL TARGET A
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva
Experimental: PROPOFOL + REMIFENTANIL TARGET B
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva
Experimental: PROPOFOL + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva
Experimental: PROPOFOL + REMIFENTANIL TARGET D
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva
Experimental: PROPOFOL + REMIFENTANIL TARGET E
The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva
Experimental: PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva
Experimental: PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C
The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70.
Drug: Propofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nociception level index (NoI)
Time Frame: Between induction and first incision
The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.
Between induction and first incision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular parameters
Time Frame: Between induction and first incision
Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.
Between induction and first incision
Movement
Time Frame: Between induction and first incision
Visible occurence of movement during painfull stimuli.
Between induction and first incision
Depth of anesthesia
Time Frame: Between induction and first incision
Depth of anesthesia is measured by a Bispectral Index monitor. Changes in depth of anesthesia will be recorded during painfull stimuli
Between induction and first incision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

Medasense Biometrics Ltd

Investigators

  • Principal Investigator: Albert Dahan, MD, PhD, Professor, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL43511.058.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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