The Medasense Study

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Pain

Treatments: Drug: Propofol; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01912118

NL43511.058.13

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 8 patient groups

PROPOFOL ONLY GROUP

Experimental group

Description:

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.

Treatment:

Drug: Propofol

PROPOFOL + REMIFENTANIL TARGET A

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol

PROPOFOL + REMIFENTANIL TARGET B

Experimental group

Description:

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

Treatment:

Drug: Remifentanil

Drug: Propofol

PROPOFOL + REMIFENTANIL TARGET C

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol

PROPOFOL + REMIFENTANIL TARGET D

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol

PROPOFOL + REMIFENTANIL TARGET E

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol

PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol

PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C

Experimental group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Propofol