No registrations found.
ID
Source
Brief title
Health condition
analgesia, anesthesia, anaesthesia, peroperative, opioid consumption, nociception, monitoring.
analgesie, anesthesie, perioperatief, pijn, nociceptie, opiaat consumptie,
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Opioid and propofol consumption in total dose and dose/min; and
2. Incidence (number of episodes) and total duration of inadequate anesthesia.
Secondary outcome
1. Differences in Pk (prediction probability) values of NoL, BIS, HR and MAP for
predicting the balance of nociception-anti nociception during the following
states
• Awake vs. loss of consiousness (LOC)
• Anesthesia (after discontinuation of propofol and remifentanil) vs. opening
eyes
• LOC vs intubation
• Normal stimulation vs maximum stimulation (as indicated by the surgeon);
2. Incidence of NoL values < 10 and > 20;
3. Time from reversal of neuromuscular blockade to extubation;
4. Pain and sedation scores, incidence of nausea/vomiting, hemodynamics,
respiration and medication use (e.g. opioids and antiemetics) in the recovery
room obtained at 15-min interval;
5. PACU: time until Aldrete > 9 (readiness for discharge);
6. Incidence of memory/awareness.
Background summary
The NoL is a multi-parameter non-linear combination of heart rate (HR),
heart rate variability (HRV), amplitude of the finger photo-plethysmogram (AP), skin
conductance, fluctuations in skin conductance, and their time derivatives, derived
from Random Forrest regression. This is a unique algorithmic modeling approach that
combines various inputs and identifies complex nonlinear interactions. In a previous
study, the NoL outperformed the mean arterial pressure and heart rate as indices for
nociception and anti nociception.
In this trial, we randomize 80 patients to receive either NoL guided anesthesia or standard of care anesthesia. We hypothize that NoL guided anetshesia will result in lower peroperative opioid consumption, greater hemodynamic stability and faster recoverytimes than standard of care anesthesia.
Study objective
We hypothesize that, compared with standard management, NoL-guided anesthesia
will lead to reduced incidence of inadequate anesthesia (see Table 1) and increased
hemodynamic stability. Furthermore, we hypothesize that NoL-guided anesthesia
leads to reduced recovery times, reduced postoperative pain scores and PONV and
faster PACU discharge (readiness) times.
Study design
Measurements will take place continuously from the moment the patient arrives in the OR to the moment the patient leaves the OR. This can take up to several hours.
In the PACU, measurements will take place every 15 minutes untill the patient is deemed fit for discharge to the ward based on pre-defined criteria.
Intervention
NoL-guided anesthesia versus standard of care.
Inclusion criteria
1. Age: 18-80 years;
2. ASA I-II-III
3. Elective open abdominal surgery or laparoscopic assisted abdominal surgery.
Exclusion criteria
1. Unable to give written informed consent;
2. Use of epidural analgesia or local anesthesia (eg. transversus abdominal plain
block, TAP block)
3. Non-elective surgery
4. Pregnancy/lactation;
5. BMI > 35 kg/m2;
6. Uncontrolled preoperative hypo- or hypertension (Mean arterial pressure < 60
mmHg or > 100 mmHg)
7. Preoperative Heart rate < 45/min or > 90/min;
8. Central nervous system disorder (neurologic/head trauma/uncontrolled
epileptic seizures);
9. Illicit substance or alcohol abuse within 30 days;
10. Chronic use of pain medication within 30 days;
11. Chronic use of psychoactive drugs within 30 days;
12. Significant medical condition
a. Untreated or persistent peripheral or central cardiovascular disease
b. Severe pulmonary disease e.g. COPD gold 4 , FEV< 1.0 L/s, or (evidence
of) elevated paCO2 > 6.0 kPa
c. Significant hepatic disease with increased bilirubin, INR or low albumin
13. Beta blocker use
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5799 |
| NTR-old | NTR6074 |
| CCMO | NL56370.058.15 |
| OMON | NL-OMON42622 |