Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable pain

Timeline

Completed

Started Jul 2013

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

July 1, 2013

Completed

24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

July 25, 2013

Last Update Submit

April 2, 2015

Conditions

Pain

Keywords

NociceptionGeneral anesthesia

Outcome Measures

Primary Outcomes (1)

Nociception level index (NoI)
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 Outcomes (3)

Cardiovascular parameters
Between induction and first incision
Movement
Between induction and first incision
Depth of anesthesia
Between induction and first incision

Study Arms (8)

PROPOFOL ONLY GROUP

EXPERIMENTAL

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 + REMIFENTANIL TARGET A

EXPERIMENTAL

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.