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Completed

NCT Number: NCT01912118

The Medasense Study

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)

Other names: Diprivan

Remifentanil

Drug

Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)

Other names: Ultiva

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cardiovascular parameters

    Time frame: Between induction and first incision

    Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.

  2. Movement

    Time frame: Between induction and first incision

    Visible occurence of movement during painfull stimuli.

  3. 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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Medasense Biometrics Ltd

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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