Pain
Conditions
Keywords
Nociception, General anesthesia
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.
Interventions
DRUGPropofol
Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
DRUGRemifentanil
Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
Sponsors
Medasense Biometrics Ltd
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nociception level index (NoI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular parameters | Between induction and first incision | Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude. |
| Movement | Between induction and first incision | Visible occurence of movement during painfull stimuli. |
| Depth of anesthesia | 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 |
Countries
Netherlands
Outcome results
None listed