Trial record 20 of 34 for:    Open Studies | "Pain Perception"

The Medasense Study

This study is currently recruiting participants.
Verified July 2013 by Leiden University Medical Center
Sponsor:
Collaborator:
Medasense Biometrics Ltd
Information provided by (Responsible Party):
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01912118
First received: July 25, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pain
Drug: Propofol
Drug: Remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Measurement of Nociceptive Index During General Anesthesia in ASA 1‐3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Nociception level index (NoI) [ Time Frame: Between induction and first incision ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cardiovascular parameters [ Time Frame: Between induction and first incision ] [ Designated as safety issue: No ]
    Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.

  • Movement [ Time Frame: Between induction and first incision ] [ Designated as safety issue: No ]
    Visible occurence of movement during painfull stimuli.

  • Depth of anesthesia [ Time Frame: Between induction and first incision ] [ Designated as safety issue: No ]
    Depth of anesthesia is measured by a Bispectral Index monitor. Changes in depth of anesthesia will be recorded during painfull stimuli


Estimated Enrollment: 96
Study Start Date: July 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: 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 Name: Diprivan
Drug: Remifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Other Name: Ultiva

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912118

Contacts
Contact: Albert Dahan, MD, PhD, Professor +31 71 52 62301 a.dahan@lumc.nl

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands
Principal Investigator: Albert Dahan, MD, PhD, Professor         
Sponsors and Collaborators
Leiden University Medical Center
Medasense Biometrics Ltd
Investigators
Principal Investigator: Albert Dahan, MD, PhD, Professor Leiden University Medical Center
  More Information

Publications:
Responsible Party: Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01912118     History of Changes
Other Study ID Numbers: NL43511.058.13
Study First Received: July 25, 2013
Last Updated: July 29, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Leiden University Medical Center:
Nociception
General anesthesia

Additional relevant MeSH terms:
Propofol
Remifentanil
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014