The Medasense Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Remifentanil

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Remifentanil

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

Intervention Type DRUG

Other Intervention Names

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Diprivan Ultiva

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No