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The NoLA study

- candidate number25469
- NTR NumberNTR6074
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-okt-2016
- Secondary IDsNL 56370.058.15 (METC) 
- Public TitleThe NoLA study
- Scientific TitleNociceptive-Level (NoL)-guided analgesia versus standard practice during general remifentanil/propofol anesthesia in ASA 1-3 patients
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedVerdoving, Perioperative care, Pain
- Inclusion criteria1. Age: 18-80 years;
3. Elective open abdominal surgery or laparoscopic assisted abdominal surgery.
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-jul-2016
- planned closingdate1-aug-2017
- Target number of participants80
- InterventionsNoL-guided anesthesia versus standard of care.
- Primary outcome1. Opioid and propofol consumption in total dose and dose/min; and
2. Incidence (number of episodes) and total duration of inadequate anesthesia.
- Secondary outcome1. 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.
- TimepointsMeasurements 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.
- Trial web sitenone
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
prof dr Albert Dahan
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD28-okt-2016 - 10-nov-2016

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