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Nociceptive-Level (NoL)-guided analgia versus standerd practice during general remifentanil/propofol anesthesia in ASA 1-3 patients


- candidate number26777
- NTR NumberNTR6500
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2017
- Secondary IDsp16019 NL56370.058.15
- Public TitleNociceptive-Level (NoL)-guided analgia versus standerd practice during general remifentanil/propofol anesthesia in ASA 1-3 patients
- Scientific TitleNociceptive-Level (NoL)-guided analgia versus standerd practice during general remifentanil/propofol anesthesia in ASA 1-3 patients
- ACRONYMNoLA
- hypothesisWe hypothesize that, compared with standard management, NoL-guided anesthesia will lead to reduced incidence of inadequate anesthesia 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, Analgesia, Nociception, Intraoperative pain-measurement, Hemodynamics
- Inclusion criteria1. Age: 18-80 years;
2. ASA I-II-III
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/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-jul-2016
- planned closingdate1-jul-2018
- Target number of participants80
- InterventionsNociceptive level guided analgesia
- 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.
- TimepointsPerioperative period: intraoperative analgesia consumption and haemodynamics; postoperative pain, medication use, nausea/vomiting
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Medasense
- Funding
(Source(s) of Monetary or Material Support)
Medasense
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD28-feb-2017 - 10-jul-2017


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